510(k) DEN200029
- Device
- Parallel
- Applicant
- Mahana Therapeutics, Inc.
- 510(k) number
- DEN200029
- Product code
- QMY
- Decision
- Unknown (DENG)
- Decision date
- 2020-11-25
- Date received
- 2020-04-30
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jean-Noel Courvoisier
- Address
- 230 California St. Suite 302 San Francisco CA US 94111 94111
Source Documents#
510(k) summary PDF not indicated by FDA