OPM SLIT LAMP MODEL P-1 & MODEL P-3— 510(k) K863048

Name: FDA 510(k) clearance K863048
Creator: U.S. Food and Drug Administration
Published: 1986-09-03

Substantially Equivalent

Optek Medico Co., Ltd.

FDA 510(k) clearance K863048 for OPM SLIT LAMP MODEL P-1 & MODEL P-3, Substantially Equivalent on 1986-09-03. Applicant: Optek Medico Co., Ltd.. Device class: 2.

Clearance details

Applicant: Optek Medico Co., Ltd.
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 1986-08-12
Decision date: 1986-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiyoda-Ku Tokyo Japan, JP

Download summary PDF View on FDA.gov ↗

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