TRC-NW400 NON-MYDRIATIC RETINAL CAMERA— 510(k) K141481
Substantially EquivalentTopcon Corporation
FDA 510(k) clearance K141481 for TRC-NW400 NON-MYDRIATIC RETINAL CAMERA, Substantially Equivalent on 2014-09-17. Applicant: Topcon Corporation. Device class: 2.
Clearance details
- Applicant
- Topcon Corporation
- 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
- Traditional
- Location
- North Reading, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.