510(k) K212143
K212143 is an FDA 510(k) premarket notification submitted by Neteera Technologies , Ltd. for the device "Neteera 130H/131H Vital Sign Monitoring Sensor". The FDA issued a decision of Substantially Equivalent on September 28, 2022. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Neteera Technologies , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2022
- Date Received
- July 9, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type