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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, predicted values, pulmonary function
510(k) Number K854745
Device Name CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM
Applicant
VERSACOR, INC.
405 GRAND AVE.
DAYTON,  OH  45405
Applicant Contact SPERO M ALEX
Correspondent
VERSACOR, INC.
405 GRAND AVE.
DAYTON,  OH  45405
Correspondent Contact SPERO M ALEX
Regulation Number868.1890
Classification Product Code
BTY  
Date Received11/26/1985
Decision Date 01/10/1986
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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