510(k) K223515
- Device
- MamaLift Plus
- Applicant
- Curio Digital Therapeutics, Inc.
- 510(k) number
- K223515
- Product code
- SAP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-22
- Date received
- 2022-11-22
- Regulation
- 882.5801
- Classification name
- Computerized Behavioral Therapy Device For Depressive Disorders.
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sidhartha Shankar
- Address
- 100 Overlook Ctr Floor 2 Princeton NJ US 08540 08540
FDA Registration Numbers#
- 3031465632
- 3010447004
- 3036503508
Source Documents#
Other 510(k) Records For Product Code SAP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231209 | Rejoyn | Otsuka America Pharmaceutical, Inc. | 2024-03-30 |