Frigitronics adapter— 510(k) K180195

Substantially Equivalent

Phakos

FDA 510(k) clearance K180195 for Frigitronics adapter, Substantially Equivalent on 2018-03-16. Applicant: Phakos. Device class: 2.

Clearance details

Applicant: Phakos
Product code: Code HRN
Device class: Class 2
Regulation: 21 CFR 886.4170
Advisory panel: Ophthalmic
Date received: 2018-01-24
Decision date: 2018-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreuil, FR

Download summary PDF View on FDA.gov ↗

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