Clearance Summary
IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER received FDA 510(k) clearance under submission number K941404, sponsored by Hogan & Hartson. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1994-06-29.
- Submission: K941404
- Applicant / Sponsor: Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5325
- Decision date: 1994-06-29
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.