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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 K960010
Device Name SERVO VENTILATOR 300 COMPUTER INTERFACE
Applicant
SIEMENS ELEMA AB
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact STEVEN CLARKE
Correspondent
SIEMENS ELEMA AB
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact STEVEN CLARKE
Regulation Number868.5895
Classification Product Code
CBK  
Date Received01/02/1996
Decision Date 10/25/1996
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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