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.. Device class: 2.

Clearance details

Applicant: Ophthalmos , Ltd.
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2006-05-08
Decision date: 2006-05-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Ickleton, Cambridge, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.