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FDA 510(k)

BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER

K-Number: K993010 · 2000-05-30

ApplicantEnvironmental Tectonics Corp.
Decision Date2000-05-30
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Environmental Tectonics Corp.. It received FDA 510(k) clearance on 2000-05-30 under 510(k) number K993010. 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 BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER?

BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER is a medical device that received FDA 510(k) clearance on 2000-05-30. The listed applicant is Environmental Tectonics Corp.. The 510(k) number is K993010.

When did BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER receive FDA 510(k) clearance?

BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER received FDA 510(k) clearance on 2000-05-30, under 510(k) number K993010.

Who is the listed applicant for BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER?

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

What is the FDA product code for BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER?

The FDA product code for BARA-MED, ACRYLIC 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.

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Other records listing Environmental Tectonics 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.

K092991O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)K020974BARA-MED ACRYLIC 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

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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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