FDA 510(k)

reSET-O

Número K: K173681 · 2018-12-10

Data da decisão2018-12-10

Código do produtoPWE

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

reSET-O is the device name listed in this FDA 510(k) record. The listed applicant is Pear Therapeutics, Inc.. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K173681. The device is classified under product code PWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the reSET-O?

reSET-O is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Pear Therapeutics, Inc.. The 510(k) number is K173681.

When did reSET-O receive FDA 510(k) clearance?

reSET-O received FDA 510(k) clearance on 2018-12-10, under 510(k) number K173681.

Who is the listed applicant for reSET-O?

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

What is the FDA product code for reSET-O?

The FDA product code for reSET-O is PWE.

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