Clearance Summary
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 received FDA 510(k) clearance under submission number K011980, sponsored by Pace Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-09-12.
- Submission: K011980
- Applicant / Sponsor: Pace Medical
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3600
- Decision date: 2001-09-12
Classification & Regulation
This clearance is catalogued under FDA product code DTE and 21 CFR 870.3600, within the Cardiovascular review panel as a Class II device.