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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K871366
Device Name SIEMENS MAIN FLOW BACTERIA FILTER
Applicant
Siemens Elema AB
2360 N. Palmer Dr.
P.O. Box 94517
Schaumburg,  IL  60195
Applicant Contact ELLEN FARNEY
Correspondent
Siemens Elema AB
2360 N. Palmer Dr.
P.O. Box 94517
Schaumburg,  IL  60195
Correspondent Contact ELLEN FARNEY
Regulation Number868.5260
Classification Product Code
CAH  
Date Received04/07/1987
Decision Date 05/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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