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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name compressor, air, portable
510(k) Number K023354
Device Name COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
Applicant
SIEMENS ELEMA AB
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Applicant Contact STEVE SHEEHAN
Correspondent
SIEMENS ELEMA AB
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Correspondent Contact STEVE SHEEHAN
Regulation Number868.6250
Classification Product Code
BTI  
Date Received10/07/2002
Decision Date 09/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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