Clearance Summary
DEFIBRILLATOR CABLE TESTER, MODEL DT2200 received FDA 510(k) clearance under submission number K061606, sponsored by Medical Devices/Padpro, 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 2006-06-21.
- Submission: K061606
- Applicant / Sponsor: Medical Devices/Padpro, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2006-06-21
Classification & Regulation
This clearance is catalogued under FDA product code DRG and 21 CFR 870.2910, within the Cardiovascular review panel as a Class II device.