Clearance Summary
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR received FDA 510(k) clearance under submission number K991293, sponsored by Fischer Medical Technologies, 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 2000-05-05.
- Submission: K991293
- Applicant / Sponsor: Fischer Medical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1750
- Decision date: 2000-05-05
Classification & Regulation
This clearance is catalogued under FDA product code JOQ and 21 CFR 870.1750, within the Cardiovascular review panel as a Class II device.