K162014 is an FDA 510(k) clearance for the Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Bluepoint Medical GmbH & Co. KG (Selmsdorf, DE). The FDA issued a Cleared decision on February 6, 2017, 200 days after receiving the submission on July 21, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K162014 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2016 |
| Decision Date | February 06, 2017 |
| Days to Decision | 200 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 |