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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, continuous, facility use
510(k) Number K970839
Device Name SERVO VENTILATOR 300A
Original Applicant
SIEMENS ELEMA AB
rontgenvagen 2
s-17195 solna,  SE
Original Contact ann-christine jonsson
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/07/1997
Decision Date 10/14/1997
Decision (ST)
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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