FDA 510(k)

HTU3

K-Number: K984313 · 1999-10-22

Decision Date1999-10-22

Product CodeCBF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

HTU3 is the device name listed in this FDA 510(k) record. The listed applicant is Hyox Systems , Ltd.. It received FDA 510(k) clearance on 1999-10-22 under 510(k) number K984313. 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 HTU3?

HTU3 is a medical device that received FDA 510(k) clearance on 1999-10-22. The listed applicant is Hyox Systems , Ltd.. The 510(k) number is K984313.

When did HTU3 receive FDA 510(k) clearance?

HTU3 received FDA 510(k) clearance on 1999-10-22, under 510(k) number K984313.

Who is the listed applicant for HTU3?

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

What is the FDA product code for HTU3?

The FDA product code for HTU3 is CBF.

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 Network K171899Revitalair 430FOxavita Srl K163109OxyHeal 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.