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FDA 510(k)

RECIRCULATION KIT #7-510-18

K-Number: K914402 · 1991-11-27

ApplicantNorthgate Technologies, Inc.
Decision Date1991-11-27
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RECIRCULATION KIT #7-510-18 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 1991-11-27 under 510(k) number K914402. 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 RECIRCULATION KIT #7-510-18?

RECIRCULATION KIT #7-510-18 is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K914402.

When did RECIRCULATION KIT #7-510-18 receive FDA 510(k) clearance?

RECIRCULATION KIT #7-510-18 received FDA 510(k) clearance on 1991-11-27, under 510(k) number K914402.

Who is the listed applicant for RECIRCULATION KIT #7-510-18?

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 RECIRCULATION KIT #7-510-18?

The FDA product code for RECIRCULATION KIT #7-510-18 is HIF.

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Other records listing Northgate Technologies, Inc. as applicant

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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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