Clearance Summary
BIOMODULE 3-M1 received FDA 510(k) clearance under submission number K123658, sponsored by Zephyr Technology Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-04-24.
- Submission: K123658
- Applicant / Sponsor: Zephyr Technology Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 2013-04-24
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.