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FDA 510(k)

MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS

K-Number: K002795 · 2000-12-06

ApplicantHypertec, Inc.
Decision Date2000-12-06
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Hypertec, Inc.. It received FDA 510(k) clearance on 2000-12-06 under 510(k) number K002795. 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 MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS?

MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS is a medical device that received FDA 510(k) clearance on 2000-12-06. The listed applicant is Hypertec, Inc.. The 510(k) number is K002795.

When did MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS receive FDA 510(k) clearance?

MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS received FDA 510(k) clearance on 2000-12-06, under 510(k) number K002795.

Who is the listed applicant for MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS?

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

What is the FDA product code for MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS?

The FDA product code for MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS 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 Hypertec, 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.

K002794MODEL 5000 MULTIPLACE HYPERBARIC THERAPY

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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