physIQ Personalized Physiology Analytics Engine 2
by Physiq, Inc
physIQ Personalized Physiology Analytics Engine 2 is a Class II device made by Physiq, Inc, cleared under FDA 510(k) K142512 on 11 Jun 2015 and listed in FDA GUDID since 10 Jan 2022 (UDI-DI 00860004366263), 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 | GUDID listing | Number00860004366263 | Date10 Jan 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142512 | Date11 Jun 2015 | StatusActive |
Official records
- AccessGUDID record 00860004366263
- FDA 510(k) database K142512
Across registries
- FDA 510(k) K142512 decided 11 Jun 2015 Active
- FDA GUDID UDI-DI 00860004366263 listed 10 Jan 2022 Listed
Timeline
- Cleared FDA 510(k) K142512
- Listed FDA GUDID 00860004366263
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- physIQ Personalized Physiology Analytics Engine
- Generic name
- Electrocardiography telemetric monitoring system
- Model / reference
- 2
- Primary DI / UDI-DI
- 00860004366263
- 510(k) Number
- FDA product code
- PLB
- GMDN term
- Electrocardiography telemetric monitoring system
- Device class
- Class II
- Regulation number
- 870.2300
- GUDID distribution status
- In Commercial Distribution
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