510(k) DEN200029
DEN200029 is an FDA 510(k) premarket notification submitted by Mahana Therapeutics, Inc. for the device "Parallel". The FDA issued a decision of De Novo granted on Nov 25, 2020. The device falls under product code QMY (Computerized Behavioral Therapy Device For Treating Symptoms), a Class II device regulated under 21 CFR 876.5960. Mahana Therapeutics, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Nov 25, 2020
- Date Received
- Apr 30, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computerized Behavioral Therapy Device For Treating Symptoms
- Device Class
- Class II
- Regulation Number
- 876.5960
- Review Panel
- GU
- Submission Type
- 510(k)
A computerized behavioral therapy device for treating symptoms of gastrointestinal conditions is a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to patients with gastrointestinal conditions.