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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 K905480
Device Name SPIROSCOPE
Applicant
GRANDCOR MEDICAL SYSTEMS
405 GRAND AVE.
DAYTON,  OH  45405
Applicant Contact SPERO M ALEX
Correspondent
GRANDCOR MEDICAL SYSTEMS
405 GRAND AVE.
DAYTON,  OH  45405
Correspondent Contact SPERO M ALEX
Regulation Number868.1880
Classification Product Code
BZC  
Date Received12/06/1990
Decision Date 05/06/1991
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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