iPac® Pachymeter 16040
iPac Pachymeter 16040 is an ultrasound pachymeter (FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Reichert Inc., cleared under FDA 510(k) K030610 on 21 Mar 2003 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00812559011228), 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 | Number00812559011228 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK030610 | Date21 Mar 2003 | StatusActive |
Official records
- AccessGUDID record 00812559011228
- FDA 510(k) database K030610
Across registries
- FDA 510(k) K030610 decided 21 Mar 2003 Active
- FDA GUDID UDI-DI 00812559011228 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K030610
- Listed FDA GUDID 00812559011228
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iPac® Pachymeter
- Generic name
- Ultrasound pachymeter
- Model / reference
- 16040
- Primary DI / UDI-DI
- 00812559011228
- 510(k) Number
- FDA product code
- IYO
- GMDN term
- Ultrasound pachymeter
- Device class
- Class II
- Regulation number
- 892.1560
- GUDID distribution status
- In Commercial Distribution
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