FDA.reportPublic FDA data

510(k) K211372

Device
Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application For Irritable Bowel Syndrome (IBS)
Applicant
Mahana Therapeutics Inc.
510(k) number
K211372
Product code
QMY  
Decision
Substantially Equivalent (SESE)
Decision date
2021-06-02
Date received
2021-05-04
Regulation
876.5960
Classification name
Computerized Behavioral Therapy Device For Treating Symptoms
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jean-Noel Courvoisier
Address
One Market, Spear Tower 36th Floor San Francisco CA US 94105 94105

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QMY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K211463ReguloraMetame Health, Inc.2021-11-24
DEN200029ParallelMahana Therapeutics, Inc.2020-11-25

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases