Clearance Summary
VITAL SIGNS MONITOR, PROPAQ LT received FDA 510(k) clearance under submission number K033378, sponsored by Welch Allyn Protocol, 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 2004-03-01.
- Submission: K033378
- Applicant / Sponsor: Welch Allyn Protocol, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2004-03-01
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.