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FDA 510(k)

MODEL 5000 MULTIPLACE HYPERBARIC THERAPY

K-Number: K002794 · 2000-12-06

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

Device Summary

MODEL 5000 MULTIPLACE HYPERBARIC THERAPY 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 K002794. 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 5000 MULTIPLACE HYPERBARIC THERAPY?

MODEL 5000 MULTIPLACE HYPERBARIC THERAPY 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 K002794.

When did MODEL 5000 MULTIPLACE HYPERBARIC THERAPY receive FDA 510(k) clearance?

MODEL 5000 MULTIPLACE HYPERBARIC THERAPY received FDA 510(k) clearance on 2000-12-06, under 510(k) number K002794.

Who is the listed applicant for MODEL 5000 MULTIPLACE HYPERBARIC THERAPY?

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 5000 MULTIPLACE HYPERBARIC THERAPY?

The FDA product code for MODEL 5000 MULTIPLACE HYPERBARIC THERAPY 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 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.

K002795MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS

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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