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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, gas, oxygen, partial pressure, blood-phase, indwelling
510(k) Number K935778
Device Name VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM
Applicant
VIA MEDICAL CORP.
11425 SORRENTO VALLEY RD.
SAN DIEGO,  CA  92121
Applicant Contact DAN MCKAY
Correspondent
VIA MEDICAL CORP.
11425 SORRENTO VALLEY RD.
SAN DIEGO,  CA  92121
Correspondent Contact DAN MCKAY
Regulation Number868.1200
Classification Product Code
CCE  
Subsequent Product Codes
CCC   LZF  
Date Received12/03/1993
Decision Date 12/05/1996
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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