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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K812041
Device Name VENTI-MONITOR MODEL 101
Applicant
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2600
Classification Product Code
CAP  
Date Received07/21/1981
Decision Date 09/25/1981
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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