510(k) K231209
- Device
- Rejoyn
- Applicant
- Otsuka America Pharmaceutical, Inc.
- 510(k) number
- K231209
- Product code
- SAP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-30
- Date received
- 2023-04-27
- 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
- Nancy Teague
- Address
- 2440 Research Blvd. Rockville MD US 20850 20850
FDA Registration Numbers#
- 3031465632
- 3010447004
- 3036503508
Source Documents#
Other 510(k) Records For Product Code SAP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223515 | MamaLift Plus | Curio Digital Therapeutics, Inc. | 2024-04-22 |