DIGITAL RETINAL CAMERA— 510(k) K111612
Substantially EquivalentCanon, Inc.
FDA 510(k) clearance K111612 for DIGITAL RETINAL CAMERA, Substantially Equivalent on 2011-09-14. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Honkomagome, Bunkyo-Ku Tokyo, JP
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