510(k) K060739

MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 by Khrunichev State Research & Production Space Centr — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2006
Date Received
March 20, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Hyperbaric
Device Class
Class II
Regulation Number
868.5470
Review Panel
AN
Submission Type