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FDA 510(k) Application Details - K120577
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K120577
Device Name
Spirometer, Diagnostic
Applicant
MEDIKRO OY
KELLOLAHDENTIE 27
KUOPIO FI-70460 FI
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Contact
MIKKO ELORANTA
Other 510(k) Applications for this Contact
Regulation Number
868.1840
More FDA Info for this Regulation Number
Classification Product Code
BZG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/27/2012
Decision Date
06/24/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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