RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP— 510(k) K083771

Substantially Equivalent

Clarity Medical Systems

FDA 510(k) clearance K083771 for RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP, Substantially Equivalent on 2009-01-30. Applicant: Clarity Medical Systems. Device class: 2.

Clearance details

Applicant
Clarity Medical Systems
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
Pleasanton, CA, US
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