K152563 is an FDA 510(k) clearance for the Pulse Oximeter (MD300M/MD300K2). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Beijing Choice Electronic Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on April 18, 2016, 222 days after receiving the submission on September 9, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K152563 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2015 |
| Decision Date | April 18, 2016 |
| Days to Decision | 222 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 |