Patient Monitor
22 catalogue numbers from MM17, listed by Edan Instruments, Inc., China, under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms). 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
22catalogue numbers in this listing
17510(k) clearances naming this product code
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 | Edan Instruments, Inc., China |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K113653 |
| Record published | 2016-09-01 |
| Record revised | 2026-05-04 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MM17 | In distribution | |
| PM-2000A | In distribution | |
| UX15 | In distribution | |
| PM-2000A Pro | In distribution | |
| iM60 | In distribution | |
| iX12 | In distribution | |
| PM-2000XL Pro | In distribution | |
| iM8A | In distribution | |
| M80 | In distribution | |
| PM-2000XL | In distribution | |
| PM-2000XL Plus | In distribution | |
| elite V8 | In distribution | |
| iM20 | In distribution | |
| iM50 | In distribution | |
| iM80 | In distribution | |
| iM8 | In distribution | |
| CX15 | In distribution | |
| iM8B | In distribution | |
| PM-2000M | In distribution | |
| iM70 | In distribution | |
| elite V6 | In distribution | |
| M50 | In distribution |
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 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| 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 |
|---|---|
| K251508 | 2026-08-06 |
| K250179 | 2025-07-29 |
| K240320 | 2024-06-28 |
| K232962 | 2024-04-19 |
| K232694 | 2024-02-05 |
| K220308 | 2022-08-11 |
| K202336 | 2021-01-23 |
| K192514 | 2020-04-02 |
| K161056 | 2017-02-03 |
| K160981 | 2016-12-22 |
| K152552 | 2016-04-29 |
| K131971 | 2014-03-20 |
| K120727 | 2013-06-21 |
| K120173 | 2012-05-16 |
| K113653 | 2012-02-06 |
| K113623 | 2012-02-01 |
| K110922 | 2011-07-20 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Edan Diagnostics, Inc. | 510(k) number | 2025-10-24 | Class II | Device Design | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | 14550 | |
| Edan Diagnostics, Inc. | 510(k) number | 2025-10-24 | Class II | Device Design | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | 342 | |
| Edan Diagnostics, Inc. | 510(k) number | 2025-10-24 | Class II | Device Design | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | 377 | |
| Edan Diagnostics, Inc. | 510(k) number | 2025-10-24 | Class II | Device Design | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | 379 | |
| Edan Diagnostics, Inc. | 510(k) number | 2025-10-24 | Class II | Device Design | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | 3141 | |
| Edan Diagnostics, Inc. | 510(k) number | 2016-06-23 | Class II | Nonconforming Material/Component | Incorrect CO2 readings with some patient monitors. | 521 | 2016-11-16 |
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.