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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K893760
Device Name CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004
Applicant
Nova-Ventrx
4309 Regency Dr.
Wheeling,  IL  60025
Applicant Contact BERNARD R PALUCH
Correspondent
Nova-Ventrx
4309 Regency Dr.
Wheeling,  IL  60025
Correspondent Contact BERNARD R PALUCH
Regulation Number868.5975
Classification Product Code
BZO  
Date Received05/19/1989
Decision Date 08/10/1989
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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