K933090 is an FDA 510(k) clearance for the EZ-SPACER. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Airpharma, LLC (Ramona, US). The FDA issued a Cleared decision on February 10, 1994, 231 days after receiving the submission on June 24, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K933090 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1993 |
| Decision Date | February 10, 1994 |
| Days to Decision | 231 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 |