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FDA 510(k)

DGH 55 HANDHELD PACHYMETER (PACHMATE)

K-Number: K033385 · 2003-11-07

ApplicantDgh Technology, Inc.
Decision Date2003-11-07
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DGH 55 HANDHELD PACHYMETER (PACHMATE) 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 2003-11-07 under 510(k) number K033385. 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 55 HANDHELD PACHYMETER (PACHMATE)?

DGH 55 HANDHELD PACHYMETER (PACHMATE) is a medical device that received FDA 510(k) clearance on 2003-11-07. The listed applicant is Dgh Technology, Inc.. The 510(k) number is K033385.

When did DGH 55 HANDHELD PACHYMETER (PACHMATE) receive FDA 510(k) clearance?

DGH 55 HANDHELD PACHYMETER (PACHMATE) received FDA 510(k) clearance on 2003-11-07, under 510(k) number K033385.

Who is the listed applicant for DGH 55 HANDHELD PACHYMETER (PACHMATE)?

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 55 HANDHELD PACHYMETER (PACHMATE)?

The FDA product code for DGH 55 HANDHELD PACHYMETER (PACHMATE) 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 AK965127DGH MODEL 9000K920906DGH-500 PACHYMETERK913067DGH-4000 A-SCAN/PACHYMETERK872726DGH-3000A A-SCAN

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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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