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FDA 510(k)

DGH MODEL 9000

K-Number: K965127 · 1997-03-17

ApplicantDgh Technology, Inc.
Decision Date1997-03-17
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DGH MODEL 9000 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 1997-03-17 under 510(k) number K965127. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DGH MODEL 9000?

DGH MODEL 9000 is a medical device that received FDA 510(k) clearance on 1997-03-17. The listed applicant is Dgh Technology, Inc.. The 510(k) number is K965127.

When did DGH MODEL 9000 receive FDA 510(k) clearance?

DGH MODEL 9000 received FDA 510(k) clearance on 1997-03-17, under 510(k) number K965127.

Who is the listed applicant for DGH MODEL 9000?

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 MODEL 9000?

The FDA product code for DGH MODEL 9000 is HQC.

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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)K920906DGH-500 PACHYMETERK913067DGH-4000 A-SCAN/PACHYMETERK872726DGH-3000A A-SCAN

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Related Devices (Code: HQC)

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.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

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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