K050104 is an FDA 510(k) clearance for the APEX MEDICAL MININEB & MINIPLUS. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Apex Medical Corp. (Tucheng City, Taipei County, TW). The FDA issued a Cleared decision on February 16, 2005, 29 days after receiving the submission on January 18, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K050104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2005 |
| Decision Date | February 16, 2005 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |