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510(k) K050424

ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 by Fim Medical — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2005
Date Received
February 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

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