Paceart Optima™ System POS12D16
Paceart Optima™ System POS12D16 is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K110693 on 8 Jun 2011 and listed in FDA GUDID since 7 May 2016 (UDI-DI 00643169707351), 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 | Number00643169707351 | Date7 May 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110693 | Date8 Jun 2011 | StatusActive |
Official records
- AccessGUDID record 00643169707351
- FDA 510(k) database K110693
Across registries
- FDA 510(k) K110693 decided 8 Jun 2011 Active
- FDA GUDID UDI-DI 00643169707351 listed 7 May 2016 Listed
Timeline
- Cleared FDA 510(k) K110693
- Listed FDA GUDID 00643169707351
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Paceart Optima™ System
- Generic name
- Patient health record information system application software
- Model / reference
- POS12D16
- Primary DI / UDI-DI
- 00643169707351
- 510(k) Number
- FDA product code
- DXH, DPS, KRE, OUG
- GMDN term
- Patient health record information system application software
- Device class
- Class II
- Regulation number
- 870.2920, 870.2340, 870.3640, 880.6310
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Patient health record information system application software.