K180380 is an FDA 510(k) clearance for the vital signs monitor. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on December 21, 2018, 312 days after receiving the submission on February 12, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K180380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2018 |
| Decision Date | December 21, 2018 |
| Days to Decision | 312 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 |