510(k) K233337
- Device
- Freespira Breathing System
- Applicant
- Freespira, Inc.
- 510(k) number
- K233337
- Product code
- SEN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-24
- Date received
- 2023-09-29
- Regulation
- 882.5050
- Classification name
- Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Contact
- Thomas Simon
- Address
- 12020 113th Ave. NE, Suite 215 Kirkland WA US 98034 98034
FDA Registration Numbers#
- 3010887638
Source Documents#
510(k) summary PDF not indicated by FDA