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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K921306
Device Name ARGIS PULMONARY FUNCTION TESTING SYSTEM
Applicant
Med Science
12151 Blackfoot Trl.
Jacksonville,  FL  32223
Applicant Contact TED TABOR
Correspondent
Med Science
12151 Blackfoot Trl.
Jacksonville,  FL  32223
Correspondent Contact TED TABOR
Regulation Number868.1880
Classification Product Code
BZC  
Date Received03/18/1992
Decision Date 06/25/1993
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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