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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, Halothane, Gaseous-Phase (Anesthetic Conc.)
510(k) Number K953795
Device Name VITALMAX 4100
Applicant
PACE TECH, INC.
510 GARDEN AVE. NORTH
CLEARWATER,  FL  33755
Applicant Contact ILHAN M BILGUTAY
Correspondent
PACE TECH, INC.
510 GARDEN AVE. NORTH
CLEARWATER,  FL  33755
Correspondent Contact ILHAN M BILGUTAY
Regulation Number868.1620
Classification Product Code
CBS  
Date Received08/14/1995
Decision Date 07/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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