Clearance Summary
Neteera 130H/131H Vital Sign Monitoring Sensor received FDA 510(k) clearance under submission number K212143, sponsored by Neteera Technologies , 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 2022-09-28.
- Submission: K212143
- Applicant / Sponsor: Neteera Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2022-09-28
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.