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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 K861487
Device Name ST-90 SPIRO ANALIZER
Applicant
FUTURE IMPEX CORP.
2076 DEER PARK AVE.
DEERPARK,  NY  11729
Applicant Contact MORAD DAVOUDZADEH
Correspondent
FUTURE IMPEX CORP.
2076 DEER PARK AVE.
DEERPARK,  NY  11729
Correspondent Contact MORAD DAVOUDZADEH
Regulation Number868.1890
Classification Product Code
BTY  
Date Received04/11/1986
Decision Date 06/23/1986
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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