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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K952267
Device Name CRITERION, CRITERION I.V., MODIFIED
Applicant
NOVA-VENTRX
1974 RAYMOND DR.
NORTHBROOK,  IL  60062
Applicant Contact BERNARD R PALUCH
Correspondent
NOVA-VENTRX
1974 RAYMOND DR.
NORTHBROOK,  IL  60062
Correspondent Contact BERNARD R PALUCH
Regulation Number868.5270
Classification Product Code
BZE  
Date Received05/15/1995
Decision Date 12/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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