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FDA 510(k)

PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2

K-Number: K021689 · 2002-10-24

ApplicantPan-America Hyperbarics, Inc.
Decision Date2002-10-24
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2 is the device name listed in this FDA 510(k) record. The listed applicant is Pan-America Hyperbarics, Inc.. It received FDA 510(k) clearance on 2002-10-24 under 510(k) number K021689. 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 PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2?

PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2 is a medical device that received FDA 510(k) clearance on 2002-10-24. The listed applicant is Pan-America Hyperbarics, Inc.. The 510(k) number is K021689.

When did PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2 receive FDA 510(k) clearance?

PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2 received FDA 510(k) clearance on 2002-10-24, under 510(k) number K021689.

Who is the listed applicant for PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2?

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

What is the FDA product code for PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2?

The FDA product code for PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2 is CBF.

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Other records listing Pan-America Hyperbarics, 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.

K122560VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1K021690PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1K021693PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1

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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