Clearance Summary
EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 received FDA 510(k) clearance under submission number K903966, sponsored by Bio-Tek Instruments, 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 1991-06-19.
- Submission: K903966
- Applicant / Sponsor: Bio-Tek Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3630
- Decision date: 1991-06-19
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.