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FDA 510(k)

HI-FLO THERME PNEU 45, WISAP #7083, 7083V

K-Number: K031014 · 2003-06-27

ApplicantWisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Decision Date2003-06-27
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HI-FLO THERME PNEU 45, WISAP #7083, 7083V is the device name listed in this FDA 510(k) record. The listed applicant is Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. It received FDA 510(k) clearance on 2003-06-27 under 510(k) number K031014. 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 HI-FLO THERME PNEU 45, WISAP #7083, 7083V?

HI-FLO THERME PNEU 45, WISAP #7083, 7083V is a medical device that received FDA 510(k) clearance on 2003-06-27. The listed applicant is Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. The 510(k) number is K031014.

When did HI-FLO THERME PNEU 45, WISAP #7083, 7083V receive FDA 510(k) clearance?

HI-FLO THERME PNEU 45, WISAP #7083, 7083V received FDA 510(k) clearance on 2003-06-27, under 510(k) number K031014.

Who is the listed applicant for HI-FLO THERME PNEU 45, WISAP #7083, 7083V?

The FDA 510(k) record lists Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI-FLO THERME PNEU 45, WISAP #7083, 7083V?

The FDA product code for HI-FLO THERME PNEU 45, WISAP #7083, 7083V is HIF.

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Other records listing Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh 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.

K011510MULTI HI-FLO PNEU, WISAP #7080K992481CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMFK992513THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMFK990662DISPOSABLE HEATING TUBING SET #7642HSESK982515POWER-DRIVE, WISAP MODEL #7688PD/7688PD1K982518AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608

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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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