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FDA 510(k)

SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES

K-Number: K031649 · 2003-12-05

ApplicantFink Engineering Pty, Ltd.
Decision Date2003-12-05
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES is the device name listed in this FDA 510(k) record. The listed applicant is Fink Engineering Pty, Ltd.. It received FDA 510(k) clearance on 2003-12-05 under 510(k) number K031649. 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 SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES?

SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES is a medical device that received FDA 510(k) clearance on 2003-12-05. The listed applicant is Fink Engineering Pty, Ltd.. The 510(k) number is K031649.

When did SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES receive FDA 510(k) clearance?

SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES received FDA 510(k) clearance on 2003-12-05, under 510(k) number K031649.

Who is the listed applicant for SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES?

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

What is the FDA product code for SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES?

The FDA product code for SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES 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 Fink Engineering Pty, Ltd. 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.

K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber

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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