Clearance Summary
SYNAP-I INFANT SENSORY ASSESSMENT UNIT received FDA 510(k) clearance under submission number K810138, sponsored by Infant Hearing Assessment Foundation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1981-04-03.
- Submission: K810138
- Applicant / Sponsor: Infant Hearing Assessment Foundation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1900
- Decision date: 1981-04-03
Classification & Regulation
This clearance is catalogued under FDA product code GWJ and 21 CFR 882.1900, within the Neurology review panel as a Class II device.