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FDA 510(k)

SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER

K-Number: K974868 · 1998-07-02

ApplicantPerry Baromedical Corp.
Decision Date1998-07-02
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Perry Baromedical Corp.. It received FDA 510(k) clearance on 1998-07-02 under 510(k) number K974868. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER?

SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER is a medical device that received FDA 510(k) clearance on 1998-07-02. The listed applicant is Perry Baromedical Corp.. The 510(k) number is K974868.

When did SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER receive FDA 510(k) clearance?

SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER received FDA 510(k) clearance on 1998-07-02, under 510(k) number K974868.

Who is the listed applicant for SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER?

The FDA 510(k) record lists Perry Baromedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER?

The FDA product code for SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER is CBF.

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 Perry Baromedical Corp. 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.

K072427SIGMA SERIES HYPERBARIC CHAMBERK990927SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER

Related Devices (Code: CBF)

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.

K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd.K220290Revitalair 430+Us Hyperbaric NetworkK171899Revitalair 430FOxavita SrlK163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal Medical Systems, Inc.K102831RSI 4200Reimers Systems, 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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