Clearance Summary
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER received FDA 510(k) clearance under submission number K954391, 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 1995-11-17.
- Submission: K954391
- Applicant / Sponsor: Bio-Tek Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5325
- Decision date: 1995-11-17
Classification & Regulation
This clearance is catalogued under FDA product code DRL and 21 CFR 870.5325, within the Cardiovascular review panel as a Class II device.