Multiple Measurement Calbox MM Calbox
Multiple Measurement Calbox MM Calbox is an ultrasound pachymeter (FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Dgh Technology Inc., cleared under FDA 510(k) K920906 on 2 Nov 1992 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 00857377006315), 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 | Number00857377006315 | Date11 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK920906 | Date2 Nov 1992 | StatusActive |
Official records
- AccessGUDID record 00857377006315
- FDA 510(k) database K920906
Across registries
- FDA 510(k) K920906 decided 2 Nov 1992 Active
- FDA GUDID UDI-DI 00857377006315 listed 11 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K920906
- Listed FDA GUDID 00857377006315
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Multiple Measurement Calbox
- Generic name
- Ultrasound pachymeter
- Model / reference
- MM Calbox
- Primary DI / UDI-DI
- 00857377006315
- 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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