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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K951129
Device Name NOVATRANS II
Applicant
Medex, Inc.
3637 Lacon Rd.
Hilliard,  OH  43026
Applicant Contact CATHY CHENETSKI
Correspondent
Medex, Inc.
3637 Lacon Rd.
Hilliard,  OH  43026
Correspondent Contact CATHY CHENETSKI
Regulation Number870.2850
Classification Product Code
DRS  
Date Received03/13/1995
Decision Date 04/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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