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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K871293
Device Name SERVO NEBULIZER 945 SIEMENS-ELEMA AB
Applicant
SIEMENS ELEMA AB
2360 NORTH PALMER DR.
P.O. BOX 94517
SCHAUMBURG,  IL  60195
Applicant Contact ELLEN FARNEY
Correspondent
SIEMENS ELEMA AB
2360 NORTH PALMER DR.
P.O. BOX 94517
SCHAUMBURG,  IL  60195
Correspondent Contact ELLEN FARNEY
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/31/1987
Decision Date 05/08/1987
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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