Clearance Summary
AMPLITONE-3 received FDA 510(k) clearance under submission number K812676, sponsored by Progressive Technology, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1981-10-13.
- Submission: K812676
- Applicant / Sponsor: Progressive Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.1875
- Decision date: 1981-10-13
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.