HAAG-STREIT FUNDUS MODULE 300— 510(k) K163021

Substantially Equivalent

Optomed OY

FDA 510(k) clearance K163021 for HAAG-STREIT FUNDUS MODULE 300, Substantially Equivalent on 2017-04-11. Applicant: Optomed OY. Device class: 2.

Clearance details

Applicant: Optomed OY
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2016-10-31
Decision date: 2017-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oulu, FI

Download summary PDF View on FDA.gov ↗

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