Clearance Summary
MyHomeDoc received FDA 510(k) clearance under submission number K202483, sponsored by Myhomedoc , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-03-23.
- Submission: K202483
- Applicant / Sponsor: Myhomedoc , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1875
- Decision date: 2021-03-23
Classification & Regulation
This clearance is catalogued under FDA product code DQD and 21 CFR 870.1875, within the Cardiovascular review panel as a Class II device.