Surveyor Central
Patient Monitoring Central Station
9manufacturers in China registered for this device type
71catalogue numbers in this listing
7510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Mortara Instrument, Inc., United States |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| 510(k) | K060135 |
| Record published | 2017-06-14 |
| Record revised | 2023-03-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment humidity up to 90 % RH; Handling environment temperature up to 60 °C |
| Distribution end date | 2023-03-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCNODE-GAB-XXDXX | In distribution | |
| SCSYS-IAE-DFFAX | In distribution | |
| SCSYS-HAE-BDFCX | Withdrawn | |
| SCSYS-IAE-SDFAX | Withdrawn | |
| SCREP-AAA-XXXXX | Withdrawn | |
| SCREV-AAA-BXXAX | Withdrawn | |
| SCSYS-IAE-SDFCX | Withdrawn | |
| SCNODE-DAA-BXXFX | Withdrawn | |
| SCNODE-AAA-AKDEX | Withdrawn | |
| SCNODE-EAA-BCXXX | Withdrawn | |
| SCNODE-CAA-AXBEX | Withdrawn | |
| SCSYS-HAE-CBFCA | Withdrawn | |
| SCNODE-CAA-BXBEX | Withdrawn | |
| SCREP-AAA-XXBXX | Withdrawn | |
| SCSYS-HAE-RHFCA | Withdrawn | |
| SCREP-BAA-XXXXX | Withdrawn | |
| SCNODE-GAA-XXDDX | Withdrawn | |
| SCNODE-BAA-BXXFX | Withdrawn | |
| SCNODE-DAA-AXXEX | Withdrawn | |
| SCSYS-IAE-AFFAX | Withdrawn | |
| SCSYS-IAF-FBFAX | Withdrawn | |
| SCNODE-AAA-AJBEX | Withdrawn | |
| SCAC-AAA-EXCXX | Withdrawn | |
| SCSYS-HAE-GDAAX | Withdrawn | |
| SCNODE-AAA-DJBEX | Withdrawn | |
| SCNODE-BAA-XKXFX | Withdrawn | |
| SCSYS-IAE-FFFAX | Withdrawn | |
| SCREV-AAA-BXXXX | Withdrawn | |
| SCSYS-IAE-BBFAX | Withdrawn | |
| SCNODE-DAA-AXXFX | Withdrawn | |
| SCNODE-BAA-BLXFX | Withdrawn | |
| SCSYS-IAE-TFFAX | Withdrawn | |
| SCNODE-BAA-AJXEX | Withdrawn | |
| SCNODE-AAA-AXBEX | Withdrawn | |
| SCNODE-DAA-CKXEX | Withdrawn | |
| SCNODE-CAA-DXBEX | Withdrawn | |
| SCSYS-IAE-TBFAX | Withdrawn | |
| SCNODE-AAA-EKBEX | Withdrawn | |
| SCSYS-HAE-SHFCX | Withdrawn | |
| SCNODE-AAA-AJBXX | Withdrawn | |
| SCSYS-HAE-RDFCA | Withdrawn | |
| SCNODE-CAA-CXBEX | Withdrawn | |
| SCSYS-HAE-UBFAX | Withdrawn | |
| SCNODE-GAA-XXDEX | Withdrawn | |
| SCNODE-AAA-DXBEX | Withdrawn | |
| SCAC-AAA-EXDXX | Withdrawn | |
| SCNODE-DAA-BXBEX | Withdrawn | |
| SCNODE-BAA-XLXFX | Withdrawn | |
| SCAC-AAA-CXBXX | Withdrawn | |
| SCSYS-HAE-RHFAA | Withdrawn | |
| SCNODE-AAA-BKBXX | Withdrawn | |
| SCNODE-AAA-BJBEX | Withdrawn | |
| SCAC-AAA-DXDXX | Withdrawn | |
| SCNODE-BAA-EKXFX | Withdrawn | |
| SCSYS-IAE-SBFAX | Withdrawn | |
| SCNODE-BAA-AKXEX | Withdrawn | |
| SCSYS-IAF-FBFAA | Withdrawn | |
| SCNODE-AAA-AOBEX | Withdrawn | |
| SCSYS-IAE-ABFAX | Withdrawn | |
| SCNODE-BAA-EMXEX | Withdrawn | |
| SCSYS-IAE-BFFAX | Withdrawn | |
| SCNODE-BAA-AKXFX | Withdrawn | |
| SCSYS-HAE-BDFCA | Withdrawn | |
| SCNODE-DAA-BXXEX | Withdrawn | |
| SCSYS-HAE-UBFAA | Withdrawn | |
| SCNODE-AAA-EXBEX | Withdrawn | |
| SCSYS-HAE-GHCCX | Withdrawn | |
| SCSYS-HAE-CHFAA | Withdrawn | |
| SCSYS-HAE-SHCCA | Withdrawn | |
| SCAC-AAA-CXDXX | Withdrawn | |
| SCNODE-GAA-XXDXX | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 20 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173765 | 2018-09-04 |
| K161517 | 2017-01-11 |
| K160685 | 2016-08-04 |
| K141811 | 2014-11-19 |
| K131929 | 2013-12-03 |
| K123556 | 2013-03-22 |
| K060135 | 2006-05-15 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-10-07 | Class II | Device Design | Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole patter | 624 | 2015-02-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.