K192343 is an FDA 510(k) clearance for the Patient Monitor. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Creative Industry Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 31, 2019, 125 days after receiving the submission on August 28, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K192343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2019 |
| Decision Date | December 31, 2019 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |