Z5 Slit lamp microscope, Z2 Slit lamp microscope— 510(k) K152535

Name: FDA 510(k) clearance K152535
Creator: U.S. Food and Drug Administration
Published: 2016-05-26

Substantially Equivalent

Takagi Seiko Co., Ltd.

FDA 510(k) clearance K152535 for Z5 Slit lamp microscope, Z2 Slit lamp microscope, Substantially Equivalent on 2016-05-26. Applicant: Takagi Seiko Co., Ltd.. Device class: 2.

Clearance details

Applicant: Takagi Seiko Co., Ltd.
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2015-09-04
Decision date: 2016-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nakano, JP

Download summary PDF View on FDA.gov ↗

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