Clearance Summary
MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) received FDA 510(k) clearance under submission number K913533, sponsored by Hewlett-Packard Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-11-07.
- Submission: K913533
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 1991-11-07
Classification & Regulation
This clearance is catalogued under FDA product code DXH and 21 CFR 870.2920, within the Cardiovascular review panel as a Class II device.