Portable Slit Lamp Microscope— 510(k) K162778

Name: FDA 510(k) clearance K162778
Creator: U.S. Food and Drug Administration
Published: 2017-07-21

Substantially Equivalent

Suzhou Kangjie Medical, Inc.

FDA 510(k) clearance K162778 for Portable Slit Lamp Microscope, Substantially Equivalent on 2017-07-21. Applicant: Suzhou Kangjie Medical, Inc.. Device class: 2.

Clearance details

Applicant: Suzhou Kangjie Medical, Inc.
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2016-09-30
Decision date: 2017-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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