Matrix Wearable
M5 Recorder, 4-Lead Patient Cable RL Lead AHA, System Kit 00815187020556; M5 Recorder 00815187020471; M5 4-Lead Patient Cable - RL Lead AHA 00815187020549; M5 USB Cable 1-Meter
4manufacturers in China registered for this device type
12catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (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 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Creative Industry Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Biox Instruments Co Ltd | Wuxi | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Global Instrumentation, LLC, United States |
|---|---|
| FDA product code | DSH |
| Device type | Recorder, Magnetic Tape, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K202456 |
| Record published | 2021-03-11 |
| Record revised | 2021-08-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 009-400-0192 | In distribution | |
| 009-400-0178 | In distribution | |
| 009-400-0168 | In distribution | |
| 009-400-0171 | In distribution | |
| M5 | In distribution | |
| 009-400-0205 | In distribution | |
| 009-400-0206 | In distribution | |
| 009-400-0169 | In distribution | |
| 009-400-0195 | In distribution | |
| 009-400-0194 | In distribution | |
| 009-400-0193 | In distribution | |
| 009-400-0167 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 33 |
| CardioSTAT | Icentia Inc | 6 |
| Holter ECG and ABP System | Edan Instruments, Inc. | 5 |
| Epatch Sensor | Braemar Manufacturing, LLC | 5 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 4 |
| Nuubo System | Smart Solutions Technologies SL | 4 |
| VitaloJAK | Vitalograph Ireland Ltd. | 4 |
| Care Assist | Philips Medizin Systeme Böblingen GmbH | 4 |
| AT-Patch | ATsens Co., Ltd. | 3 |
| Cuff ABPMpro without ECG | Somnomedics AG | 3 |
| Vasomedical-Biox™ Arcs S/W Dongle – Mini 1200/1201 2 & 3 CH ECG | Vasomedical, Inc. | 3 |
| ECG Leadwire Set for CM 3000 Series | Getemed Medizin- UND Informationstechnik AG | 3 |
Showing 12 of 122. All products under Recorder, Magnetic Tape, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202456 | 2020-12-29 |
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.