Mypatch
510(k) K131190
Mypatch is a Class II device made by dms-service, LLC, cleared under FDA 510(k) K131190 on 29 Oct 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131190 | Date29 Oct 2013 | StatusActive |
Official records
- FDA 510(k) database K131190
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DSH
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2800
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K131190
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Electrode, Holter, Button, 1 ea., MP2E-01 Model 1200 | A10-1200-04 / Model 1200 | 00817980020702 | On the market | |
| Electrodes, Holter, Button, 20 per Box, MP2E-20 Model 1200 | A10-1200-02 / Model 1200 | 00817980020689 | On the market | |
| Electrodes, Holter, Button, 40 per Box, MP2E-40 Model 1200 | A10-1200-03 / Model 1200 | 00817980020696 | On the market | |
| Vasomedical-Biox™ 1200 ECG Holter Mini Recorder Model 1200 | A10-1200-01 / Model 1200 | 00817980020344 | On the market | |
| Vasomedical-Biox™ Model 1200 2 CH Mini ECG Recorder Model 1200 Kit | A10-1200-00 / Model 1200 Kit | 00817980020368 | On the market |