Clearance Summary
PALPATION ENHANCER received FDA 510(k) clearance under submission number K801811, sponsored by Medical Horizons Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1980-09-09.
- Submission: K801811
- Applicant / Sponsor: Medical Horizons Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.1875
- Decision date: 1980-09-09
Classification & Regulation
This clearance is catalogued under FDA product code LDE and 21 CFR 870.1875, within the Cardiovascular review panel as a Class I device.