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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 Interpretor (Diagnostic)
510(k) Number K851706
Device Name UNIVERSAL COMPUTER INTERFACE SYSTEM
Applicant
Vacumetrics, Inc.
2261 Palma Dr.
Ventura,  CA  93003
Applicant Contact RONALD A THOMSON
Correspondent
Vacumetrics, Inc.
2261 Palma Dr.
Ventura,  CA  93003
Correspondent Contact RONALD A THOMSON
Regulation Number868.1900
Classification Product Code
BZM  
Date Received04/25/1985
Decision Date 05/03/1985
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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