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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 K050424
Device Name ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50
Applicant
FIM MEDICAL
PO BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
FIM MEDICAL
PO BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number868.1840
Classification Product Code
BZG  
Date Received02/18/2005
Decision Date 06/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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