MicroER
by Lifewatch
MicroER is a Class II device made by Lifewatch, cleared under FDA 510(k) K963725 on 10 Sep 1997 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00850725007057), active as of 20 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850725007057 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK963725 | Date10 Sep 1997 | StatusActive |
Official records
- AccessGUDID record 00850725007057
- FDA 510(k) database K963725
Across registries
- FDA 510(k) K963725 decided 10 Sep 1997 Active
- FDA GUDID UDI-DI 00850725007057 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K963725
- Listed FDA GUDID 00850725007057
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrocardiography telemetric monitoring system transmitter
- Model / reference
- MicroER
- Primary DI / UDI-DI
- 00850725007057
- 510(k) Number
- FDA product code
- DXH
- GMDN term
- Electrocardiography telemetric monitoring system transmitter
- Device class
- Class II
- Regulation number
- 870.2920
- GUDID distribution status
- In Commercial Distribution
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