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FDA 510(k)

Frigitronics adapter

K-Number: K180195 · 2018-03-16

ApplicantPhakos
Decision Date2018-03-16
Product CodeHRN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Frigitronics adapter is a medical device manufactured by Phakos. It received FDA 510(k) clearance on 2018-03-16 under approval number K180195. 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 Frigitronics adapter?

Frigitronics adapter is a medical device that received FDA 510(k) clearance on 2018-03-16. It is manufactured by Phakos. The 510(k) number is K180195.

When was Frigitronics adapter approved by the FDA?

Frigitronics adapter received FDA 510(k) clearance on 2018-03-16, under approval number K180195.

What company makes Frigitronics adapter?

Frigitronics adapter is manufactured by Phakos.

What is the FDA product code for Frigitronics adapter?

The FDA product code for Frigitronics adapter is HRN.

Other Devices by Phakos

K162756PHAKOS Disposable Retinal Cryo Probe K173944Endocular Viewing Lenses and Silicone Ring K200911MIRA Adapter

Related Devices (Code: HRN)

K162756PHAKOS Disposable Retinal Cryo ProbePhakos K160591D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BV K200911MIRA 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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