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FDA 510(k)

TOPICAL HYPERBARIC OXYGEN CHAMBER

K-Number: K861593 · 1986-05-12

ApplicantStephenson Industries, Inc.
Decision Date1986-05-12
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TOPICAL HYPERBARIC OXYGEN CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Stephenson Industries, Inc.. It received FDA 510(k) clearance on 1986-05-12 under 510(k) number K861593. 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 HYPERBARIC OXYGEN CHAMBER?

TOPICAL HYPERBARIC OXYGEN CHAMBER is a medical device that received FDA 510(k) clearance on 1986-05-12. The listed applicant is Stephenson Industries, Inc.. The 510(k) number is K861593.

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

TOPICAL HYPERBARIC OXYGEN CHAMBER received FDA 510(k) clearance on 1986-05-12, under 510(k) number K861593.

Who is the listed applicant for TOPICAL HYPERBARIC OXYGEN CHAMBER?

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

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

The FDA product code for TOPICAL 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Stephenson Industries, 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.

K963777HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100K861101THE NEW FLEXIBLE COLLAPSIBLE CHAMBERK853971REGULATOR-INHALATOR SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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