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FDA 510(k)

TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER

K-Number: K920948 · 1992-08-11

ApplicantTopox Therapeuutic Rentals, Inc.
Decision Date1992-08-11
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Topox Therapeuutic Rentals, Inc.. It received FDA 510(k) clearance on 1992-08-11 under 510(k) number K920948. 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 TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER?

TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER is a medical device that received FDA 510(k) clearance on 1992-08-11. The listed applicant is Topox Therapeuutic Rentals, Inc.. The 510(k) number is K920948.

When did TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER receive FDA 510(k) clearance?

TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER received FDA 510(k) clearance on 1992-08-11, under 510(k) number K920948.

Who is the listed applicant for TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER?

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

What is the FDA product code for TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER?

The FDA product code for TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER is KPJ.

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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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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