K101953 is an FDA 510(k) clearance for the SMDIA-1000. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Southmedic, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on January 7, 2011, 179 days after receiving the submission on July 12, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K101953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2010 |
| Decision Date | January 07, 2011 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |