Clearance Summary
TRUECPR COACHING DEVICE received FDA 510(k) clearance under submission number K123597, sponsored by Physio-Control, 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 2013-04-17.
- Submission: K123597
- Applicant / Sponsor: Physio-Control, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5210
- Decision date: 2013-04-17
Classification & Regulation
This clearance is catalogued under FDA product code LIX and 21 CFR 870.5210, within the Cardiovascular review panel as a Class II device.