FDA 510(k)

Perin Health System (PHD80060-2)

Número K: K252984 · 2026-01-22

Data da decisão2026-01-22

Código do produtoDRG

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Perin Health System (PHD80060-2) is the device name listed in this FDA 510(k) record. The listed applicant is Perin Health Devices, LLC. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K252984. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Perin Health System (PHD80060-2)?

Perin Health System (PHD80060-2) is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Perin Health Devices, LLC. The 510(k) number is K252984.

When did Perin Health System (PHD80060-2) receive FDA 510(k) clearance?

Perin Health System (PHD80060-2) received FDA 510(k) clearance on 2026-01-22, under 510(k) number K252984.

Who is the listed applicant for Perin Health System (PHD80060-2)?

The FDA 510(k) record lists Perin Health Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perin Health System (PHD80060-2)?

The FDA product code for Perin Health System (PHD80060-2) is DRG.

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Fonte oficial

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