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FDA 510(k) Application Details - K121739
Device Classification Name
Ophthalmoscope, Ac-Powered
More FDA Info for this Device
510(K) Number
K121739
Device Name
Ophthalmoscope, Ac-Powered
Applicant
OPTOVUE, INC.
45531 Northport Loop W
FREMONT, CA 94538 US
Other 510(k) Applications for this Company
Contact
Azimun Jamal
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
06/13/2012
Decision Date
01/18/2013
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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