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FDA 510(k)

HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100

K-Number: K963777 · 1997-07-28

ApplicantStephenson Industries, Inc.
Decision Date1997-07-28
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 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 1997-07-28 under 510(k) number K963777. 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 HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100?

HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 is a medical device that received FDA 510(k) clearance on 1997-07-28. The listed applicant is Stephenson Industries, Inc.. The 510(k) number is K963777.

When did HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 receive FDA 510(k) clearance?

HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 received FDA 510(k) clearance on 1997-07-28, under 510(k) number K963777.

Who is the listed applicant for HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100?

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 HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100?

The FDA product code for HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 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.

K861593TOPICAL HYPERBARIC OXYGEN CHAMBERK861101THE 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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