PACEART OPTIMA™ System POS12D14
PACEART OPTIMA™ System POS12D14 is a Class I device made by Medtronic, Inc., cleared under FDA 510(k) K110693 on 8 Jun 2011 and listed in FDA GUDID since 1 Apr 2016 (UDI-DI 00643169463523), 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 | Number00643169463523 | Date1 Apr 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110693 | Date8 Jun 2011 | StatusActive |
Official records
- AccessGUDID record 00643169463523
- FDA 510(k) database K110693
Across registries
- FDA 510(k) K110693 decided 8 Jun 2011 Active
- FDA GUDID UDI-DI 00643169463523 listed 1 Apr 2016 Listed
Timeline
- Cleared FDA 510(k) K110693
- Listed FDA GUDID 00643169463523
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- Withdrawn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
- POS12D14
- Primary DI / UDI-DI
- 00643169463523
- 510(k) Number
- FDA product code
- OUG, DXH, DPS, KRE
- GMDN term
- Patient health record information system application software
- Device class
- Class I
- Regulation number
- 880.6310, 870.2920, 870.2340, 870.3640
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Patient health record information system application software.