Matrix Holter System
M12R L Recorder, 10-Lead Cable, AHA, System Kit 90815187020184; M12R, 10 Lead patient Cable (DIN) 90815187020252; M12R Holter Recorder 90815187020320; M12R Carrying Case
2manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Hebei (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
Record
| Listed by | Global Instrumentation, LLC, United States |
|---|---|
| FDA product code | MLO |
| Device type | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K051730 |
| Record published | 2022-04-29 |
| Record revised | 2019-11-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 001-400-0107 | In distribution | |
| 001-400-0123 | In distribution | |
| M12A | In distribution | |
| 001-400-0105 | In distribution | |
| M12A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HScribe | Mortara Instrument, Inc. | 55 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 41 |
| Millennia Software | Braemar Manufacturing, LLC | 18 |
| Patient Cable | Global Instrumentation, LLC | 13 |
| Modality Manager | Mortara Instrument, Inc. | 10 |
| Norav 1200 Series PC-ECG | Norav Medical Inc. | 6 |
| GI Holter System | Global Instrumentation, LLC | 5 |
| Cardiospy ECG Holter System | Labtech Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság | 4 |
| WA Holter System | Global Instrumentation, LLC | 3 |
| Contec | Contec Medical Systems Co., Ltd. | 3 |
| Scribe | Mortara Instrument, Inc. | 2 |
| Pouch | Global Instrumentation, LLC | 2 |
Showing 12 of 33. All products under Electrocardiograph, Ambulatory, With Analysis Algorithm
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K051730 | 2005-09-26 |
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.