K201179 is an FDA 510(k) clearance for the GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable. 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 July 20, 2020, 80 days after receiving the submission on May 1, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K201179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2020 |
| Decision Date | July 20, 2020 |
| Days to Decision | 80 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 |