K911785 is an FDA 510(k) clearance for the RHINO-GUARD. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 7, 1991, 168 days after receiving the submission on April 22, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K911785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1991 |
| Decision Date | October 07, 1991 |
| Days to Decision | 168 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 |