COBRA FUNDUS CAMERA— 510(k) K132987

Substantially Equivalent

C.S.O. S.R.L.

FDA 510(k) clearance K132987 for COBRA FUNDUS CAMERA, Substantially Equivalent on 2014-07-03. Applicant: C.S.O. S.R.L.. Device class: 2.

Clearance details

Applicant: C.S.O. S.R.L.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2013-09-24
Decision date: 2014-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ormond Beach, FL, US

Download summary PDF View on FDA.gov ↗

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