HRV Acquire 5650
HRV Acquire 5650 is a Class II device made by WR Medical Electronics Co., cleared under FDA 510(k) K092809 on 19 Oct 2010 and listed in FDA GUDID since 25 Jul 2016 (UDI-DI 00702173456508), 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 | Number00702173456508 | Date25 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092809 | Date19 Oct 2010 | StatusActive |
Official records
- AccessGUDID record 00702173456508
- FDA 510(k) database K092809
Across registries
- FDA 510(k) K092809 decided 19 Oct 2010 Active
- FDA GUDID UDI-DI 00702173456508 listed 25 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K092809
- Listed FDA GUDID 00702173456508
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HRV Acquire
- Generic name
- Electrocardiograph, professional, single-channel
- Model / reference
- 5650
- Primary DI / UDI-DI
- 00702173456508
- 510(k) Number
- FDA product code
- DRT
- GMDN term
- Electrocardiograph, professional, single-channel
- Device class
- Class II
- Regulation number
- 870.2300
- GUDID distribution status
- In Commercial Distribution
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