K200141 is an FDA 510(k) clearance for the Oxi-W System. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).
Submitted by Ld Technology, LLC (Miami, US). The FDA issued a Cleared decision on April 27, 2020, 97 days after receiving the submission on January 21, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K200141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2020 |
| Decision Date | April 27, 2020 |
| Days to Decision | 97 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MWI - Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |