Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

THE NEW FLEXIBLE COLLAPSIBLE CHAMBER

K-Number: K861101 · 1986-05-06

ApplicantStephenson Industries, Inc.
Decision Date1986-05-06
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE NEW FLEXIBLE COLLAPSIBLE 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 1986-05-06 under 510(k) number K861101. 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 THE NEW FLEXIBLE COLLAPSIBLE CHAMBER?

THE NEW FLEXIBLE COLLAPSIBLE CHAMBER is a medical device that received FDA 510(k) clearance on 1986-05-06. The listed applicant is Stephenson Industries, Inc.. The 510(k) number is K861101.

When did THE NEW FLEXIBLE COLLAPSIBLE CHAMBER receive FDA 510(k) clearance?

THE NEW FLEXIBLE COLLAPSIBLE CHAMBER received FDA 510(k) clearance on 1986-05-06, under 510(k) number K861101.

Who is the listed applicant for THE NEW FLEXIBLE COLLAPSIBLE 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 THE NEW FLEXIBLE COLLAPSIBLE CHAMBER?

The FDA product code for THE NEW FLEXIBLE COLLAPSIBLE 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-100K861593TOPICAL HYPERBARIC OXYGEN 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

View on FDA Database →

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

↑