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FDA 510(k)

SYSTEM ONE HYPERBARIC CHAMBER

K-Number: K951044 · 1996-01-25

ApplicantNth Systems, Inc.
Decision Date1996-01-25
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SYSTEM ONE HYPERBARIC CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Nth Systems, Inc.. It received FDA 510(k) clearance on 1996-01-25 under 510(k) number K951044. 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 SYSTEM ONE HYPERBARIC CHAMBER?

SYSTEM ONE HYPERBARIC CHAMBER is a medical device that received FDA 510(k) clearance on 1996-01-25. The listed applicant is Nth Systems, Inc.. The 510(k) number is K951044.

When did SYSTEM ONE HYPERBARIC CHAMBER receive FDA 510(k) clearance?

SYSTEM ONE HYPERBARIC CHAMBER received FDA 510(k) clearance on 1996-01-25, under 510(k) number K951044.

Who is the listed applicant for SYSTEM ONE HYPERBARIC CHAMBER?

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

What is the FDA product code for SYSTEM ONE HYPERBARIC CHAMBER?

The FDA product code for SYSTEM ONE HYPERBARIC CHAMBER 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

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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