K212555 is an FDA 510(k) clearance for the Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on May 6, 2022, 266 days after receiving the submission on August 13, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K212555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2021 |
| Decision Date | May 06, 2022 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |