Surveyor S12
The Surveyor S12 is a portable patient monitor for continuous monitoring by healthcare professionals in a healthcare facility. It is intended for adult and pediatric patients and can be…
The Surveyor S12 is a portable patient monitor for continuous monitoring by healthcare professionals in a healthcare facility. It is intended for adult and pediatric patients and can be used in stationary or portable applications.
The Surveyor family offers selected monitoring functions for ECG, respiration, blood pressure, temperature, oxygen saturation, carbon dioxide and cardiac output. ECG functions include arrhythmia and ST-segment monitoring and resting twelve-lead recordings. Available measurements depend on the monitor’s configuration.
Central Workstation Connection
An Ethernet connection using the Mortara protocol allows patient information to be exchanged with the Surveyor Central Station. This enables the S12 to be monitored at a central workstation in addition to its local display.
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) | K123556 |
| Record published | 2016-09-24 |
| Record revised | 2023-03-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature up to 140 °F |
| Distribution end date | 2023-03-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SUR12-LAA-XXAAX | In distribution | |
| SUR12-RAA-XXAAX | In distribution | |
| SUR12-SAA-XXAAX | In distribution | |
| SUR12-LAA-XXXAX | In distribution | |
| SUR12-TAA-XXXAX | In distribution | |
| SUR12-UAA-XXXAX | In distribution | |
| SUR12-VAA-XXAAX | In distribution | |
| SUR12-WAA-XXXAX | In distribution | |
| SUR12-WAA-XXAAX | In distribution | |
| SUR12-VAA-XXXAX | In distribution | |
| SUR12-FAA-XXXAX | In distribution | |
| SUR12-RAG-FXABX | In distribution | |
| SUR12-UAA-XXAAX | In distribution | |
| SUR12-TAA-XXAAX | In distribution | |
| SUR12-SAA-XXXAX | In distribution | |
| SUR12-RAA-XXXAX | In distribution | |
| SUR12-PAA-XXAAX | Withdrawn | |
| SUR12-QAA-XXXAX | Withdrawn | |
| SUR12-RAG-EXABX | Withdrawn | |
| SUR12-SAG-FXABX | Withdrawn | |
| SUR12-PAA-XXXAX | Withdrawn | |
| SUR12-PAC-XXAAX | Withdrawn | |
| SUR12-NAA-XXAAX | Withdrawn | |
| SUR12-MAA-XXAAX | Withdrawn | |
| SUR12-DAA-XXAAX | Withdrawn | |
| SUR12-AAC-XXAAX | Withdrawn | |
| SUR12-EAA-XXAAX | Withdrawn | |
| SUR12-NAA-XXXAX | Withdrawn | |
| SUR12-MAA-XXXAX | Withdrawn | |
| SUR12-MAC-XXAAX | Withdrawn | |
| SUR12-JDG-BXAAX | Withdrawn | |
| SUR12-AAA-XXAAX | Withdrawn | |
| SUR12-QAC-XXAAX | Withdrawn | |
| SUR12-SAG-XXAAD | Withdrawn | |
| SUR12-JAA-XXAAX | Withdrawn | |
| SUR12-NAE-XXXAB | Withdrawn | |
| SUR12-QAA-XXAAX | Withdrawn | |
| SUR12-BAA-XXAAX | 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 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Mortara Instrument, Inc. | 510(k) number | 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.