The following data is part of a premarket notification filed by Neteera Technologies Ltd. with the FDA for Neteera 130h/131h Vital Sign Monitoring Sensor.
| Device ID | K212143 |
| 510k Number | K212143 |
| Device Name: | Neteera 130H/131H Vital Sign Monitoring Sensor |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | Neteera Technologies Ltd. Hebrew University Givat Ram Campus, High-tech Village - Building 1.1/ P.O. Prof Rokah 2 Jerusalem, IL 9518702 |
| Contact | Yael Himmel |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2320 Philadelphia, PA 19103 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-09 |
| Decision Date | 2022-09-28 |