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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 K953228
Device Name NARKOMED AV2+ ANESTHESIA VENTILATOR
Applicant
Draeger Medical, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Applicant Contact JAMES J BRENNAN
Correspondent
Draeger Medical, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact JAMES J BRENNAN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/10/1995
Decision Date 03/01/1996
Decision SE SUBJECT TO TRACKING REG (ST)
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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