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510(k) K191716

Device
Somryst
Applicant
Pear Therapeutics, Inc.
510(k) number
K191716
Product code
PWE  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-23
Date received
2019-06-26
Regulation
882.5801
Classification name
Computerized Behavioral Therapy Device For Psychiatric Disorders
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
David Amor
Address
201 Mission St. #1450 San Francisco CA US 94105 94105

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PWE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K173681reSET-OPear Therapeutics, Inc.2018-12-10
DEN160018reSetPear Therapeutics, Inc.2017-09-14

Legacy Summary#

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FDA Review#

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