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FDA 510(k)

BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM

K-Number: K011312 · 2001-07-18

ApplicantKhrunichev State Research & Production Space Centr
Decision Date2001-07-18
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM 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 2001-07-18 under 510(k) number K011312. 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 BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM?

BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM is a medical device that received FDA 510(k) clearance on 2001-07-18. The listed applicant is Khrunichev State Research & Production Space Centr. The 510(k) number is K011312.

When did BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM receive FDA 510(k) clearance?

BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM received FDA 510(k) clearance on 2001-07-18, under 510(k) number K011312.

Who is the listed applicant for BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM?

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 BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM?

The FDA product code for BLKS-303 MK MONOPLACE 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.

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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.

K060739MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307

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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