Clearance Summary
BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS received FDA 510(k) clearance under submission number K100310, sponsored by BTL Industries, 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 2010-10-13.
- Submission: K100310
- Applicant / Sponsor: BTL Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2010-10-13
Classification & Regulation
This clearance is catalogued under FDA product code MWJ and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.