Clearance Summary
IMPULSE 3000 DEFIBRILLATOR ANALYZER received FDA 510(k) clearance under submission number K934254, sponsored by Dynatech/Nevada, 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 1993-11-23.
- Submission: K934254
- Applicant / Sponsor: Dynatech/Nevada, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5325
- Decision date: 1993-11-23
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.