Clearance Summary
SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 received FDA 510(k) clearance under submission number K011729, sponsored by Dni Nevada, 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 2001-08-30.
- Submission: K011729
- Applicant / Sponsor: Dni Nevada, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3630
- Decision date: 2001-08-30
Classification & Regulation
This clearance is catalogued under FDA product code DTC and 21 CFR 870.3630, within the Cardiovascular review panel as a Class II device.