Clearance Summary
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT received FDA 510(k) clearance under submission number K041674, sponsored by Philips Medical Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-07-19.
- Submission: K041674
- Applicant / Sponsor: Philips Medical Systems
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2004-07-19
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.