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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 K852771
Device Name PC INTERFACE
Original Applicant
SIEMENS ELEMA AB
2360 north palmer dr.
p.o. box 94517
schaumburg,  IL  60195
Original Contact christer hellsten
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/27/1985
Decision Date 10/10/1985
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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