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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 K852308
Device Name ST-460 SPIRO ANALYZER SPIROMETER
Applicant
FUTUREMED DIV. OF FUTURE IMPEX CORP.
2076 DEER PARK AVE.
DEER PARK,  NY  11729
Applicant Contact MORED DAVOUDZADEH
Correspondent
FUTUREMED DIV. OF FUTURE IMPEX CORP.
2076 DEER PARK AVE.
DEER PARK,  NY  11729
Correspondent Contact MORED DAVOUDZADEH
Regulation Number868.1840
Classification Product Code
BZG  
Date Received05/29/1985
Decision Date 06/24/1985
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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