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Multiple Measurement Calbox MM Calbox

by Dgh Technology Inc.

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 United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K920906

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857377006315 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK920906 Date2 Nov 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K920906 decided 2 Nov 1992 Active
  • FDA GUDID UDI-DI 00857377006315 listed 11 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K920906
  2. Listed FDA GUDID 00857377006315

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

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

Similar devices

Other devices filed under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Other devices from Dgh Technology Inc.

See all devices from Dgh Technology Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)