Harmony Referral System— 510(k) K210396

Name: FDA 510(k) clearance K210396
Creator: U.S. Food and Drug Administration
Published: 2021-09-13

Substantially Equivalent

Topcon Healthcare Solutions EMEA Oy

FDA 510(k) clearance K210396 for Harmony Referral System, Substantially Equivalent on 2021-09-13. Applicant: Topcon Healthcare Solutions EMEA Oy. Device class: 2.

Clearance details

Applicant: Topcon Healthcare Solutions EMEA Oy
Product code: Code NFJ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-02-10
Decision date: 2021-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oulu, FI

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.