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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 K901308
Device Name SPIRO ANALYZER MODEL ST 250
Applicant
FUTUREMED DIV. OF FUTURE IMPEX CORP.
2076 DEER PARK AVE.
DEER PARK,  NY  11729
Applicant Contact MIKE DAVIDSON
Correspondent
FUTUREMED DIV. OF FUTURE IMPEX CORP.
2076 DEER PARK AVE.
DEER PARK,  NY  11729
Correspondent Contact MIKE DAVIDSON
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/20/1990
Decision Date 07/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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