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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K930492
Device Name IDACARE ANESTHESIA MANAGEMENT WORKSTATIN
Applicant
PREMIER ANESTHESIA SYSTEMS
1050 CONNECTICUT AVE.,N.W.
WASHINGTON,  DC  20036
Applicant Contact WAYNE MATELSKI
Correspondent
PREMIER ANESTHESIA SYSTEMS
1050 CONNECTICUT AVE.,N.W.
WASHINGTON,  DC  20036
Correspondent Contact WAYNE MATELSKI
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received02/01/1993
Decision Date 06/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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