Clearance Summary
PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES received FDA 510(k) clearance under submission number K020708, sponsored by Philips Medical Systems, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-04-25.
- Submission: K020708
- Applicant / Sponsor: Philips Medical Systems, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2002-04-25
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.