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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 K950223
Device Name DISCOVERY GRAPHIC PORTABLE SPIROMETER
Applicant
FUTUREMED AMERICA, INC.
2076 DEER PARK AVE.
DEER PARK,  NY  11729
Applicant Contact MICHAEL DAVIDSON
Correspondent
FUTUREMED AMERICA, INC.
2076 DEER PARK AVE.
DEER PARK,  NY  11729
Correspondent Contact MICHAEL DAVIDSON
Regulation Number868.1840
Classification Product Code
BZG  
Date Received01/10/1995
Decision Date 11/17/1995
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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