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FDA 510(k)

SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR

K-Number: K962683 · 1997-01-10

ApplicantDeknatel, Inc.
Decision Date1997-01-10
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1997-01-10 under 510(k) number K962683. 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 SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR?

SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Deknatel, Inc.. The 510(k) number is K962683.

When did SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR receive FDA 510(k) clearance?

SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR received FDA 510(k) clearance on 1997-01-10, under 510(k) number K962683.

Who is the listed applicant for SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR?

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

What is the FDA product code for SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR?

The FDA product code for SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR is HIF.

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Other records listing Deknatel, Inc. as applicant

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K963850PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMK964070DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAGK963098PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRK925243DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETERK930740SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL

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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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