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FDA 510(k)

MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307

K-Number: K060739 · 2006-07-21

ApplicantKhrunichev State Research & Production Space Centr
Decision Date2006-07-21
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 is the device name listed in this FDA 510(k) record. The listed applicant is Khrunichev State Research & Production Space Centr. It received FDA 510(k) clearance on 2006-07-21 under 510(k) number K060739. 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 MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307?

MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 is a medical device that received FDA 510(k) clearance on 2006-07-21. The listed applicant is Khrunichev State Research & Production Space Centr. The 510(k) number is K060739.

When did MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 receive FDA 510(k) clearance?

MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 received FDA 510(k) clearance on 2006-07-21, under 510(k) number K060739.

Who is the listed applicant for MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307?

The FDA 510(k) record lists Khrunichev State Research & Production Space Centr as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307?

The FDA product code for MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 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.

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Other records listing Khrunichev State Research & Production Space Centr 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.

K011312BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM

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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