Parallel
FDA 510(k) clearance DEN200029 · decided 2020-11-25
Clearance details
- K-number
- DEN200029
- Device name
- Parallel
- Applicant
- Mahana Therapeutics, Inc.
- Decision
- Unknown
- Date received
- 2020-04-30
- Decision date
- 2020-11-25
- Days to decision
- 209 days
- Clearance type
- Direct
- Product code
- QMY
- Device class
- 2
- Regulation number
- 876.5960
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Regulora (K211463) | Metame Health, Inc. | 2021-11-24 |
| Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) (K211372) | Mahana Therapeutics, Inc. | 2021-06-02 |
Recalls involving this device
No recalls on record reference this clearance.