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FDA 510(k)

CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR

K-Number: K920114 · 1992-04-06

ApplicantSpiess Design, Inc.
Decision Date1992-04-06
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Spiess Design, Inc.. It received FDA 510(k) clearance on 1992-04-06 under 510(k) number K920114. 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 CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR?

CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR is a medical device that received FDA 510(k) clearance on 1992-04-06. The listed applicant is Spiess Design, Inc.. The 510(k) number is K920114.

When did CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR receive FDA 510(k) clearance?

CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR received FDA 510(k) clearance on 1992-04-06, under 510(k) number K920114.

Who is the listed applicant for CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR?

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

What is the FDA product code for CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR?

The FDA product code for CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR is HIF.

Related Clinical Trials

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.

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Other records listing Spiess Design, 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.

K960347SAFETY TROCER WITH SPRINGLOADED OBDURATORK914177HYDRODISECTORK790814DELTA PUMP

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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