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FDA 510(k) Application Details - K100861
Device Classification Name
Ophthalmoscope, Ac-Powered
More FDA Info for this Device
510(K) Number
K100861
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
03/26/2010
Decision Date
06/17/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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