OPTYSE OPHTHALMOSCOPE— 510(k) K061278

Substantially Equivalent

Ophthalmos , Ltd.

FDA 510(k) clearance K061278 for OPTYSE OPHTHALMOSCOPE, Substantially Equivalent on 2006-05-16. Applicant: Ophthalmos , Ltd..

Clearance details

Applicant
Ophthalmos , Ltd.
Product code
Code HLJ
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Ickleton, Cambridge, GB
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