Clearance Summary
Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub received FDA 510(k) clearance under submission number K190073, sponsored by Current Health , 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 2019-03-27.
- Submission: K190073
- Applicant / Sponsor: Current Health , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2019-03-27
Classification & Regulation
This clearance is catalogued under FDA product code MSX and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.