Clearance Summary
RTX3320PSTN WIRELESS TELEHEALTH GATEWAY received FDA 510(k) clearance under submission number K041816, sponsored by Rtx Healthcare A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-07-19.
- Submission: K041816
- Applicant / Sponsor: Rtx Healthcare A/S
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2004-07-19
Classification & Regulation
This clearance is catalogued under FDA product code DRG and 21 CFR 870.2910, within the Cardiovascular review panel as a Class II device.