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FDA 510(k)

MILLENIUM, MODELS 2000, 2001 AND 2002

K-Number: K041007 · 2004-11-15

ApplicantHyperbaric For Life, LLC
Decision Date2004-11-15
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MILLENIUM, MODELS 2000, 2001 AND 2002 is the device name listed in this FDA 510(k) record. The listed applicant is Hyperbaric For Life, LLC. It received FDA 510(k) clearance on 2004-11-15 under 510(k) number K041007. 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 MILLENIUM, MODELS 2000, 2001 AND 2002?

MILLENIUM, MODELS 2000, 2001 AND 2002 is a medical device that received FDA 510(k) clearance on 2004-11-15. The listed applicant is Hyperbaric For Life, LLC. The 510(k) number is K041007.

When did MILLENIUM, MODELS 2000, 2001 AND 2002 receive FDA 510(k) clearance?

MILLENIUM, MODELS 2000, 2001 AND 2002 received FDA 510(k) clearance on 2004-11-15, under 510(k) number K041007.

Who is the listed applicant for MILLENIUM, MODELS 2000, 2001 AND 2002?

The FDA 510(k) record lists Hyperbaric For Life, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MILLENIUM, MODELS 2000, 2001 AND 2002?

The FDA product code for MILLENIUM, MODELS 2000, 2001 AND 2002 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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