510(k) K230814
- Device
- VRNT
- Applicant
- Cognifisense, Inc.
- 510(k) number
- K230814
- Product code
- QRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-31
- Date received
- 2023-03-24
- Regulation
- 890.5800
- Classification name
- Virtual Reality Behavioral Therapy Device For Pain Relief
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tassilo Baeuerle
- Address
- 1271 Lakeside Dr., Suite 3121 Sunnyvale CA US 94085 94085
FDA Registration Numbers#
- 3021071568
- 3042903607