TRC-50DX RETINAL CAMERA— 510(k) K123101

Substantially Equivalent

Topcon Medical Systems, Inc.

FDA 510(k) clearance K123101 for TRC-50DX RETINAL CAMERA, Substantially Equivalent on 2013-06-05. Applicant: Topcon Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant
Topcon Medical Systems, 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
Traditional
Location
North Reading, MA, US
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