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FDA 510(k) Application Details - K131939
Device Classification Name
Ophthalmoscope, Ac-Powered
More FDA Info for this Device
510(K) Number
K131939
Device Name
Ophthalmoscope, Ac-Powered
Applicant
AMICO DIAGNOSTIC INCORPORATED
445 APOLLO BEACH BLVD.
APOLLO BEACH, FL 33572 US
Other 510(k) Applications for this Company
Contact
LAUREN CHRAPOWITZKY
Other 510(k) Applications for this Contact
Regulation Number
886.1570
More FDA Info for this Regulation Number
Classification Product Code
HLI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/27/2013
Decision Date
03/26/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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