Clearance Summary
VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES received FDA 510(k) clearance under submission number K031740, 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 2003-08-26.
- Submission: K031740
- Applicant / Sponsor: Welch Allyn Protocol, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2003-08-26
Classification & Regulation
This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.