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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 K003068
Device Name SAVINA
Applicant
DRAGER MEDIZINTECHNIK GMBH
3136 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact JIM BRENNAN
Correspondent
DRAGER MEDIZINTECHNIK GMBH
3136 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact JIM BRENNAN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/02/2000
Decision Date 06/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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