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FDA 510(k)

OMNIFLATOR 6630(6-630-00)

K-Number: K973447 · 1998-09-30

ApplicantNorthgate Technologies, Inc.
Decision Date1998-09-30
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OMNIFLATOR 6630(6-630-00) is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 1998-09-30 under 510(k) number K973447. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIFLATOR 6630(6-630-00)?

OMNIFLATOR 6630(6-630-00) is a medical device that received FDA 510(k) clearance on 1998-09-30. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K973447.

When did OMNIFLATOR 6630(6-630-00) receive FDA 510(k) clearance?

OMNIFLATOR 6630(6-630-00) received FDA 510(k) clearance on 1998-09-30, under 510(k) number K973447.

Who is the listed applicant for OMNIFLATOR 6630(6-630-00)?

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

What is the FDA product code for OMNIFLATOR 6630(6-630-00)?

The FDA product code for OMNIFLATOR 6630(6-630-00) is HIF.

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Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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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