K180863 is an FDA 510(k) clearance for the FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on December 19, 2018, 261 days after receiving the submission on April 2, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K180863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2018 |
| Decision Date | December 19, 2018 |
| Days to Decision | 261 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 |