The following data is part of a premarket notification filed by Mahana Therapeutics Inc. with the FDA for Mahana Parallel Digital Cognitive Behavioral Therapy (cbt) Mobile Application For Irritable Bowel Syndrome (ibs).
| Device ID | K211372 |
| 510k Number | K211372 |
| Device Name: | Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application For Irritable Bowel Syndrome (IBS) |
| Classification | Computerized Behavioral Therapy Device For Treating Symptoms |
| Applicant | Mahana Therapeutics Inc. One Market, Spear Tower 36th Floor San Francisco, CA 94105 |
| Contact | Jean-noel Courvoisier |
| Correspondent | Jean-noel Courvoisier Mahana Therapeutics Inc. One Market, Spear Tower 36th Floor San Francisco, CA 94105 |
| Product Code | QMY |
| CFR Regulation Number | 876.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-04 |
| Decision Date | 2021-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006172015 | K211372 | 000 |