Clearance Summary
RESPIEVENTS, VERSION 4.2 received FDA 510(k) clearance under submission number K001369, sponsored by Non-Invasive Monitoring Systems, 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 2000-07-26.
- Submission: K001369
- Applicant / Sponsor: Non-Invasive Monitoring Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2000-07-26
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.