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FDA 510(k) Application Details - K100095
Device Classification Name
Chart, Visual Acuity
More FDA Info for this Device
510(K) Number
K100095
Device Name
Chart, Visual Acuity
Applicant
VIMETRICS,LLC.
311 E. BALTIMORE AVE
SUITE 100
MEDIA, PA 19063 US
Other 510(k) Applications for this Company
Contact
STEPHEN H H SINCLAIR,MD
Other 510(k) Applications for this Contact
Regulation Number
886.1150
More FDA Info for this Regulation Number
Classification Product Code
HOX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/13/2010
Decision Date
05/10/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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