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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 K933511
Device Name UPGRADED SPIROMETER ST-90
Applicant
FUTUREMED DIV. OF FUTURE IMPEX CORP.
2076 DEER PARK AVE.
DEER PARK,  NY  11729
Applicant Contact MICHAEL DAVIDSON
Correspondent
FUTUREMED DIV. OF FUTURE IMPEX CORP.
2076 DEER PARK AVE.
DEER PARK,  NY  11729
Correspondent Contact MICHAEL DAVIDSON
Regulation Number868.1890
Classification Product Code
BTY  
Date Received07/15/1993
Decision Date 02/10/1994
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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