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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
Applicant
Siemens Elema AB
Rontgenvagen 2
S-17195 Solna,  SE
Applicant Contact ANN-CHRISTINE JONSSON
Correspondent
Siemens Elema AB
Rontgenvagen 2
S-17195 Solna,  SE
Correspondent Contact ANN-CHRISTINE JONSSON
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/07/1997
Decision Date 10/14/1997
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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