Clearance Summary
ULTRA SOFTWARE MODULE: MODEL 2016 received FDA 510(k) clearance under submission number K863046, sponsored by Cardiac Pacemakers, 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 1986-12-05.
- Submission: K863046
- Applicant / Sponsor: Cardiac Pacemakers, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3700
- Decision date: 1986-12-05
Classification & Regulation
This clearance is catalogued under FDA product code KRG and 21 CFR 870.3700, within the Cardiovascular review panel as a Class III device.