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FDA 510(k)

reSET-O

K-Number: K173681 · 2018-12-10

ApplicantPear Therapeutics, Inc.
Decision Date2018-12-10
Product CodePWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the reSET-O?

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

When was reSET-O approved by the FDA?

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

What company makes reSET-O?

reSET-O is manufactured by Pear Therapeutics, Inc..

What is the FDA product code for reSET-O?

The FDA product code for reSET-O is PWE.

Other Devices by Pear Therapeutics, Inc.

DEN160018reSet K191716Somryst

Related Devices (Code: PWE)

DEN160018reSetPear Therapeutics, Inc.

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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