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FDA 510(k)

FLEXI-LITE, MODEL FL-V1.2

K-Number: K051759 · 2005-11-17

ApplicantPerformance Hyperbarics
Decision Date2005-11-17
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEXI-LITE, MODEL FL-V1.2 is the device name listed in this FDA 510(k) record. The listed applicant is Performance Hyperbarics. It received FDA 510(k) clearance on 2005-11-17 under 510(k) number K051759. 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 FLEXI-LITE, MODEL FL-V1.2?

FLEXI-LITE, MODEL FL-V1.2 is a medical device that received FDA 510(k) clearance on 2005-11-17. The listed applicant is Performance Hyperbarics. The 510(k) number is K051759.

When did FLEXI-LITE, MODEL FL-V1.2 receive FDA 510(k) clearance?

FLEXI-LITE, MODEL FL-V1.2 received FDA 510(k) clearance on 2005-11-17, under 510(k) number K051759.

Who is the listed applicant for FLEXI-LITE, MODEL FL-V1.2?

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

What is the FDA product code for FLEXI-LITE, MODEL FL-V1.2?

The FDA product code for FLEXI-LITE, MODEL FL-V1.2 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

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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