K990435 is an FDA 510(k) clearance for the BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Apex Medical Corp. (Shi-Chih, Taipei Hsien, TW). The FDA issued a Cleared decision on June 5, 2000, 480 days after receiving the submission on February 11, 1999.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K990435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1999 |
| Decision Date | June 05, 2000 |
| Days to Decision | 480 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |