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FDA 510(k)

FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER

K-Number: K970866 · 1998-01-23

ApplicantGeorgia Biomedical, Inc.
Decision Date1998-01-23
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Georgia Biomedical, Inc.. It received FDA 510(k) clearance on 1998-01-23 under 510(k) number K970866. 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 FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER?

FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER is a medical device that received FDA 510(k) clearance on 1998-01-23. The listed applicant is Georgia Biomedical, Inc.. The 510(k) number is K970866.

When did FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER receive FDA 510(k) clearance?

FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER received FDA 510(k) clearance on 1998-01-23, under 510(k) number K970866.

Who is the listed applicant for FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER?

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

What is the FDA product code for FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER?

The FDA product code for FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER 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

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

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