Clearance Summary
ERA 3000 PACING SYSTEM ANALYZER received FDA 510(k) clearance under submission number K042708, sponsored by Biotronik, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-10-20.
- Submission: K042708
- Applicant / Sponsor: Biotronik, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3600
- Decision date: 2004-10-20
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.