CANON Fundus Camera CR-10 (CR-10)— 510(k) K241049

Substantially Equivalent

Canon, Inc.

FDA 510(k) clearance K241049 for CANON Fundus Camera CR-10 (CR-10), Substantially Equivalent on 2024-05-15. Applicant: Canon, Inc.. Device class: 2.

Clearance details

Applicant: Canon, Inc.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2024-04-17
Decision date: 2024-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Kawasaki, JP

Download summary PDF View on FDA.gov ↗

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