Clearance Summary
AP-4000, AIR PULSE SENSORY STIMULATOR received FDA 510(k) clearance under submission number K964815, sponsored by Pentax Precision Instrument Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-09-04.
- Submission: K964815
- Applicant / Sponsor: Pentax Precision Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1200
- Decision date: 1997-09-04
Classification & Regulation
This clearance is catalogued under FDA product code LLN and 21 CFR 882.1200, within the Neurology review panel as a Class I device.