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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 K832431
Device Name FUKUNDA SANGYA UNITS PULMOTESTER PM60
Applicant
FUTURE IMPEX CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FUTURE IMPEX CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1840
Classification Product Code
BZG  
Date Received07/22/1983
Decision Date 09/29/1983
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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