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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 K844040
Device Name SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB
Applicant
SIEMENS ELEMA AB
2360 NORTH PALMER DR.
P.O. BOX 94517
SCHAUMBURG,  IL  60195
Applicant Contact CHRISTER HELLSTEN
Correspondent
SIEMENS ELEMA AB
2360 NORTH PALMER DR.
P.O. BOX 94517
SCHAUMBURG,  IL  60195
Correspondent Contact CHRISTER HELLSTEN
Regulation Number868.5375
Classification Product Code
BYD  
Date Received10/16/1984
Decision Date 10/25/1984
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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