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FDA 510(k)

SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM

K-Number: K983648 · 1999-02-24

ApplicantPerry Baromedical Services
Decision Date1999-02-24
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Perry Baromedical Services. It received FDA 510(k) clearance on 1999-02-24 under 510(k) number K983648. 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 SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM?

SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-24. The listed applicant is Perry Baromedical Services. The 510(k) number is K983648.

When did SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM receive FDA 510(k) clearance?

SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM received FDA 510(k) clearance on 1999-02-24, under 510(k) number K983648.

Who is the listed applicant for SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM?

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

What is the FDA product code for SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM?

The FDA product code for SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM 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 Perry Baromedical Services 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.

K930748SIGMA MP MULTIPLACE HYPERBARIC CHAMBERK895513PERRY SV-1 HYPERBARIC VENTILATORK862198SIGMA II - DUAL PLACE HYPERBARIC 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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