FDA 510(k)

MIRA Adapter

K-Number: K200911 · 2020-06-02

ApplicantPhakos

Decision Date2020-06-02

Product CodeHRN

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

MIRA Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Phakos. It received FDA 510(k) clearance on 2020-06-02 under 510(k) number K200911. The device is classified under product code HRN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIRA Adapter?

MIRA Adapter is a medical device that received FDA 510(k) clearance on 2020-06-02. The listed applicant is Phakos. The 510(k) number is K200911.

When did MIRA Adapter receive FDA 510(k) clearance?

MIRA Adapter received FDA 510(k) clearance on 2020-06-02, under 510(k) number K200911.

Who is the listed applicant for MIRA Adapter?

The FDA 510(k) record lists Phakos as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIRA Adapter?

The FDA product code for MIRA Adapter is HRN.

Other records listing Phakos as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173944Endocular Viewing Lenses and Silicone Ring K180195Frigitronics adapter K162756PHAKOS Disposable Retinal Cryo Probe

Related Devices (Code: HRN)

K180195Frigitronics adapterPhakos K162756PHAKOS Disposable Retinal Cryo ProbePhakos K160591D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BV

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.