Clearance Summary
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER received FDA 510(k) clearance under submission number K033613, 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 2003-12-08.
- Submission: K033613
- Applicant / Sponsor: Biotronik, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3720
- Decision date: 2003-12-08
Classification & Regulation
This clearance is catalogued under FDA product code DTA and 21 CFR 870.3720, within the Cardiovascular review panel as a Class II device.