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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 a medical device manufactured by Phakos. It received FDA 510(k) clearance on 2020-06-02 under approval 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. It is manufactured by Phakos. The 510(k) number is K200911.

When was MIRA Adapter approved by the FDA?

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

What company makes MIRA Adapter?

MIRA Adapter is manufactured by Phakos.

What is the FDA product code for MIRA Adapter?

The FDA product code for MIRA Adapter is HRN.

Other Devices by Phakos

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

Related Devices (Code: HRN)

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

Official Source

View on FDA Database →

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

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