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FDA 510(k)

CO2 INSUFFLATOR 1100

K-Number: K930013 · 1995-04-14

ApplicantHi Tec Medical Vertriebs-GmbH Fur Innovative Mediz
Decision Date1995-04-14
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CO2 INSUFFLATOR 1100 is the device name listed in this FDA 510(k) record. The listed applicant is Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz. It received FDA 510(k) clearance on 1995-04-14 under 510(k) number K930013. 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 1100?

CO2 INSUFFLATOR 1100 is a medical device that received FDA 510(k) clearance on 1995-04-14. The listed applicant is Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz. The 510(k) number is K930013.

When did CO2 INSUFFLATOR 1100 receive FDA 510(k) clearance?

CO2 INSUFFLATOR 1100 received FDA 510(k) clearance on 1995-04-14, under 510(k) number K930013.

Who is the listed applicant for CO2 INSUFFLATOR 1100?

The FDA 510(k) record lists Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 INSUFFLATOR 1100?

The FDA product code for CO2 INSUFFLATOR 1100 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 Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz 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.

K955477HI-TEC CO2 INSUFFLATOR TYPE 1300

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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