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FDA 510(k)

SANDS SERIES III HYPERBARIC CHAMBER

K-Number: K972908 · 1998-07-22

ApplicantSands Hyperbarics
Decision Date1998-07-22
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SANDS SERIES III HYPERBARIC CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Sands Hyperbarics. It received FDA 510(k) clearance on 1998-07-22 under 510(k) number K972908. 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 SANDS SERIES III HYPERBARIC CHAMBER?

SANDS SERIES III HYPERBARIC CHAMBER is a medical device that received FDA 510(k) clearance on 1998-07-22. The listed applicant is Sands Hyperbarics. The 510(k) number is K972908.

When did SANDS SERIES III HYPERBARIC CHAMBER receive FDA 510(k) clearance?

SANDS SERIES III HYPERBARIC CHAMBER received FDA 510(k) clearance on 1998-07-22, under 510(k) number K972908.

Who is the listed applicant for SANDS SERIES III HYPERBARIC CHAMBER?

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

What is the FDA product code for SANDS SERIES III HYPERBARIC CHAMBER?

The FDA product code for SANDS SERIES III HYPERBARIC CHAMBER is CBF.

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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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