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FDA 510(k)

DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM

K-Number: K831825 · 1983-10-27

ApplicantHospitak, Inc.
Decision Date1983-10-27
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM is the device name listed in this FDA 510(k) record. The listed applicant is Hospitak, Inc.. It received FDA 510(k) clearance on 1983-10-27 under 510(k) number K831825. The device is classified under product code KPJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM?

DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM is a medical device that received FDA 510(k) clearance on 1983-10-27. The listed applicant is Hospitak, Inc.. The 510(k) number is K831825.

When did DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM receive FDA 510(k) clearance?

DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM received FDA 510(k) clearance on 1983-10-27, under 510(k) number K831825.

Who is the listed applicant for DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM?

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

What is the FDA product code for DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM?

The FDA product code for DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM is KPJ.

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Other records listing Hospitak, 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.

K955483TRACH MASK MODEL (245, 246)K954787ILLUMINATORK953620WARM N WET HMEF W/LUER ADAPTERK953619WARM N WET HME W/LUER ADAPTERK915750DISPOSABLE BACTERIAL BREATHNG FILTERK920842AEROSOL DELIVERY SYSTEMS

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Related Devices (Code: KPJ)

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.

K250188Wound Treatment System (VHT-200)Vaporox, Inc.K212121VHT-200 Wound Treatment SystemVaporox, Inc.K190742EPIFLO-28Neogenix, LLC Dba OgenixK112634NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODPInotec Amd , Ltd.K120764EPIFLO(R)Neogenix, LLCK090681TANSCU O2Electrochemical Oxygen Concepts, Inc.

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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