MIRA Adapter— 510(k) K200911

Substantially Equivalent

Phakos

FDA 510(k) clearance K200911 for MIRA Adapter, Substantially Equivalent on 2020-06-02. 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: 2020-04-06
Decision date: 2020-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreuil, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRN

K180195 — Frigitronics adapter2018-03-16
K162756 — PHAKOS Disposable Retinal Cryo Probe2017-05-03
K160591 — D.O.R.C. Disposable Cryo Probe2017-01-23
K131787 — CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES2013-12-23
K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER2011-12-08

More clearances from Phakos

K173944 — Endocular Viewing Lenses and Silicone Ring2018-10-25

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