Clearance Summary
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120 received FDA 510(k) clearance under submission number K001664, sponsored by Agilent Technologies, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-06-30.
- Submission: K001664
- Applicant / Sponsor: Agilent Technologies, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2000-06-30
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.