Clearance Summary
REACH ACCESS TELEMEDICINE DOSE CALCULATOR received FDA 510(k) clearance under submission number K142123, sponsored by Reach Health, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2014-09-24.
- Submission: K142123
- Applicant / Sponsor: Reach Health, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1890
- Decision date: 2014-09-24
Classification & Regulation
This clearance is catalogued under FDA product code NDC and 21 CFR 868.1890, within the Anesthesiology review panel as a Class II device.