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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spirometer, diagnostic
510(k) Number K914272
Device Name KOKO SPIROMETER
Applicant
FERRARIS RESPIRATORY, INC.
P.O. BOX 400
LOUISVILLE,  CO  80027
Applicant Contact ARLIN LEHMAN
Correspondent
FERRARIS RESPIRATORY, INC.
P.O. BOX 400
LOUISVILLE,  CO  80027
Correspondent Contact ARLIN LEHMAN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/24/1991
Decision Date 07/02/1992
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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