Clearance Summary
PINWHEEL received FDA 510(k) clearance under submission number K780422, sponsored by Projects IN Health. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1978-04-04.
- Submission: K780422
- Applicant / Sponsor: Projects IN Health
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1750
- Decision date: 1978-04-04
Classification & Regulation
This clearance is catalogued under FDA product code GWY and 21 CFR 882.1750, within the Neurology review panel as a Class I device.