K221979 is an FDA 510(k) clearance for the Pulse Oximeter (Model C101A2, C101B1, C101A3). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Imdk Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 16, 2022, 103 days after receiving the submission on July 5, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K221979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2022 |
| Decision Date | October 16, 2022 |
| Days to Decision | 103 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |