Clearance Summary
Freespira received FDA 510(k) clearance under submission number K180173, sponsored by Palo Alto Health Sciences, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2018-08-23.
- Submission: K180173
- Applicant / Sponsor: Palo Alto Health Sciences, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 2018-08-23
Classification & Regulation
This clearance is catalogued under FDA product code HCC and 21 CFR 882.5050, within the Neurology review panel as a Class II device.