K222547 is an FDA 510(k) clearance for the Electric nasal aspirator. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Shenzhen Xinlianfeng Technology Co.,Ltd (Shenzhen, CN). The FDA issued a Cleared decision on October 20, 2022, 58 days after receiving the submission on August 23, 2022.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K222547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2022 |
| Decision Date | October 20, 2022 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | BTA - Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |