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FDA 510(k) Application Details - K152020
Device Classification Name
Bone Sonometer
More FDA Info for this Device
510(K) Number
K152020
Device Name
Bone Sonometer
Applicant
BONE INDEX FINLAND, LTD.
MICROKATU 1
KUOPIO 70211 FI
Other 510(k) Applications for this Company
Contact
JANNE KARJALAINEN
Other 510(k) Applications for this Contact
Regulation Number
892.1180
More FDA Info for this Regulation Number
Classification Product Code
MUA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/21/2015
Decision Date
05/13/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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