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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
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