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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Hyperbaric
510(k) Number K011312
Device Name BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
Applicant
KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR
1811 COPPER RIDGE DR.
SAN ANTONIO,  TX  78259 -3612
Applicant Contact W T WORKMAN
Correspondent
KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR
1811 COPPER RIDGE DR.
SAN ANTONIO,  TX  78259 -3612
Correspondent Contact W T WORKMAN
Regulation Number868.5470
Classification Product Code
CBF  
Date Received04/30/2001
Decision Date 07/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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