FDA 510(k)

Somryst

K-Number: K191716 · 2020-03-23

Decision Date2020-03-23

Product CodeQVO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Somryst 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 2020-03-23 under 510(k) number K191716. The device is classified under product code QVO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Somryst?

Somryst is a medical device that received FDA 510(k) clearance on 2020-03-23. The listed applicant is Pear Therapeutics, Inc.. The 510(k) number is K191716.

When did Somryst receive FDA 510(k) clearance?

Somryst received FDA 510(k) clearance on 2020-03-23, under 510(k) number K191716.

Who is the listed applicant for Somryst?

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 Somryst?

The FDA product code for Somryst is QVO.

Other records listing Pear Therapeutics, Inc. 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.

K173681reSET-O

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K233577Sleepio®Big Health, Inc.

Official Source

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