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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, Carbon-Dioxide, Gaseous-Phase
510(k) Number K930559
Device Name VITALMAX 800-C
Applicant
Pace Tech, Inc.
510 Garden Ave. N.
Clearwater,  FL  33755
Applicant Contact MARY J BILGUTAY
Correspondent
Pace Tech, Inc.
510 Garden Ave. N.
Clearwater,  FL  33755
Correspondent Contact MARY J BILGUTAY
Regulation Number868.1400
Classification Product Code
CCK  
Date Received02/03/1993
Decision Date 09/03/1993
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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