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FDA 510(k)

T CLASS HYPERBARIC FACILITIES

K-Number: K954387 · 1995-12-15

ApplicantReimers Systems, Inc.
Decision Date1995-12-15
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

T CLASS HYPERBARIC FACILITIES is the device name listed in this FDA 510(k) record. The listed applicant is Reimers Systems, Inc.. It received FDA 510(k) clearance on 1995-12-15 under 510(k) number K954387. 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 T CLASS HYPERBARIC FACILITIES?

T CLASS HYPERBARIC FACILITIES is a medical device that received FDA 510(k) clearance on 1995-12-15. The listed applicant is Reimers Systems, Inc.. The 510(k) number is K954387.

When did T CLASS HYPERBARIC FACILITIES receive FDA 510(k) clearance?

T CLASS HYPERBARIC FACILITIES received FDA 510(k) clearance on 1995-12-15, under 510(k) number K954387.

Who is the listed applicant for T CLASS HYPERBARIC FACILITIES?

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

What is the FDA product code for T CLASS HYPERBARIC FACILITIES?

The FDA product code for T CLASS HYPERBARIC 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 Reimers Systems, Inc. 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.

K102831RSI 4200K962871ODS1 - HOOD DRIVERK962869GSP1 - GAS SELECTION PANELK951125LIFEFORCE CLINICAL HYPERBARIC FACILITY

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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