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FDA 510(k)

DGH-4000 A-SCAN/PACHYMETER

K-Number: K913067 · 1992-01-31

ApplicantDgh Technology, Inc.
Decision Date1992-01-31
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DGH-4000 A-SCAN/PACHYMETER is the device name listed in this FDA 510(k) record. The listed applicant is Dgh Technology, Inc.. It received FDA 510(k) clearance on 1992-01-31 under 510(k) number K913067. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DGH-4000 A-SCAN/PACHYMETER?

DGH-4000 A-SCAN/PACHYMETER is a medical device that received FDA 510(k) clearance on 1992-01-31. The listed applicant is Dgh Technology, Inc.. The 510(k) number is K913067.

When did DGH-4000 A-SCAN/PACHYMETER receive FDA 510(k) clearance?

DGH-4000 A-SCAN/PACHYMETER received FDA 510(k) clearance on 1992-01-31, under 510(k) number K913067.

Who is the listed applicant for DGH-4000 A-SCAN/PACHYMETER?

The FDA 510(k) record lists Dgh Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DGH-4000 A-SCAN/PACHYMETER?

The FDA product code for DGH-4000 A-SCAN/PACHYMETER is IYO.

Related Clinical Trials

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Other records listing Dgh Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171301Scanmate FlexK093371MODEL DGH 6000 SCANMATE AK033385DGH 55 HANDHELD PACHYMETER (PACHMATE)K965127DGH MODEL 9000K920906DGH-500 PACHYMETERK872726DGH-3000A A-SCAN

View all 7 devices →

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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