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 the device name listed in this FDA 510(k) record. The listed applicant is Phakos. It received FDA 510(k) clearance on 2018-03-16 under 510(k) 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. The listed applicant is Phakos. The 510(k) number is K180195.

When did Frigitronics adapter receive FDA 510(k) clearance?

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

Who is the listed applicant for Frigitronics 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 Frigitronics adapter?

The FDA product code for Frigitronics 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.

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

Related Devices (Code: HRN)

K200911MIRA 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.