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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 K864105
Device Name LUNG MECHANICS SOFTWARE PROGRAM
Applicant
Siemens Elema AB
2360 N. Palmer Dr.
P.O. Box 94517
Schaumburg,  IL  60195
Applicant Contact CHRISTER HELLSTEN
Correspondent
Siemens Elema AB
2360 N. Palmer Dr.
P.O. Box 94517
Schaumburg,  IL  60195
Correspondent Contact CHRISTER HELLSTEN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/21/1986
Decision Date 11/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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