FDA Product Code
FDA Product Code QMY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5960
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211463 | Regulora | Metame Health, Inc. | 2021-11-24 | Traditional | PDF ↗ |
| K211372 | Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) | Mahana Therapeutics, Inc. | 2021-06-02 | Special | PDF ↗ |
| DEN200029 | Parallel | Mahana Therapeutics, Inc. | 2020-11-25 | Direct | — |
Product code QMY · Class II · Gastroenterology, Urology. Data: openFDA.