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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condenser, Heat And Moisture (Artificial Nose)
510(k) Number K852601
Device Name SERVO HUMIDIFIER 153
Applicant
Siemens Elema AB
2360 N. Palmer Dr.
P.O. Box 94517
Schaumburg,  IL  60195
Applicant Contact CHRISTER HELLSTEN
Correspondent
Siemens Elema AB
2360 N. Palmer Dr.
P.O. Box 94517
Schaumburg,  IL  60195
Correspondent Contact CHRISTER HELLSTEN
Regulation Number868.5375
Classification Product Code
BYD  
Date Received06/19/1985
Decision Date 07/08/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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