K212143 is an FDA 510(k) clearance for the Neteera 130H/131H Vital Sign Monitoring Sensor. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II - Special Controls, product code DRT).
Submitted by Neteera Technologies , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on September 28, 2022, 446 days after receiving the submission on July 9, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K212143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2021 |
| Decision Date | September 28, 2022 |
| Days to Decision | 446 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |