Clearance Summary
SMARTLANK WIRELESS, MODEL 001970 received FDA 510(k) clearance under submission number K033642, sponsored by Mrl, A Welch Allyn Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-05-25.
- Submission: K033642
- Applicant / Sponsor: Mrl, A Welch Allyn Company
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.5310
- Decision date: 2004-05-25
Classification & Regulation
This clearance is catalogued under FDA product code MKJ and 21 CFR 870.5310, within the Cardiovascular review panel as a Class III device.