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FDA 510(k)

DISPOSABLE, HYPERBARIC OXYGEN CHAMBER

K-Number: K840817 · 1984-04-25

ApplicantHospitak, Inc.
Decision Date1984-04-25
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE, HYPERBARIC OXYGEN CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Hospitak, Inc.. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K840817. 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 DISPOSABLE, HYPERBARIC OXYGEN CHAMBER?

DISPOSABLE, HYPERBARIC OXYGEN CHAMBER is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Hospitak, Inc.. The 510(k) number is K840817.

When did DISPOSABLE, HYPERBARIC OXYGEN CHAMBER receive FDA 510(k) clearance?

DISPOSABLE, HYPERBARIC OXYGEN CHAMBER received FDA 510(k) clearance on 1984-04-25, under 510(k) number K840817.

Who is the listed applicant for DISPOSABLE, HYPERBARIC OXYGEN CHAMBER?

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 DISPOSABLE, HYPERBARIC OXYGEN CHAMBER?

The FDA product code for DISPOSABLE, HYPERBARIC OXYGEN CHAMBER 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)K954787ILLUMINATORK953619WARM N WET HME W/LUER ADAPTERK953620WARM N WET HMEF 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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