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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 K012177
Device Name VENTVIEW, MODEL 8414095
Applicant
DRAGER MEDIZINTECHNIK GMBH
3135 QUARRY RD.
TELFORD,  PA  18969
Applicant Contact JAMES J BRENNAN
Correspondent
DRAGER MEDIZINTECHNIK GMBH
3135 QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact JAMES J BRENNAN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/12/2001
Decision Date 09/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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