K241202 is an FDA 510(k) clearance for the Electric nasal aspirator (HTD2601US). This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Hetaida Technology Co., Ltd. (Dongguan City, CN). The FDA issued a Cleared decision on July 1, 2024, 62 days after receiving the submission on April 30, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K241202 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2024 |
| Decision Date | July 01, 2024 |
| Days to Decision | 62 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 |