physiQ Heart Rhythm Module
by Physiq, Inc
510(k) K180234
physiQ Heart Rhythm Module is a Class II device made by Physiq, Inc, cleared under FDA 510(k) K180234 on 10 Aug 2018, 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 | NumberK180234 | Date10 Aug 2018 | StatusActive |
Official records
- FDA 510(k) database K180234
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DPS
- FDA applicant
- Physiq, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K180234
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 | |||
|---|---|---|---|---|
| prolaio Heart Rhythm Module 1.0 | 1.0 | 00850071330052 | — | On the market |
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