K900576 is an FDA 510(k) clearance for the MODIFIED AEROCHAMBER WITH MASK. This device is classified as a Nebulizer, Medicinal, Non-ventilatory (atomizer) (Class I - General Controls, product code CCQ).
Submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on May 13, 1991, 460 days after receiving the submission on February 7, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5640.
| 510(k) Number | K900576 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1990 |
| Decision Date | May 13, 1991 |
| Days to Decision | 460 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCQ — Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5640 |