K192633 is an FDA 510(k) clearance for the GUS831 Compressor Nebulizer. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Globalcare Medical Technology Co., Ltd. (Xiaolan Town, Zhongshan City, CN). The FDA issued a Cleared decision on May 1, 2020, 221 days after receiving the submission on September 23, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K192633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2019 |
| Decision Date | May 01, 2020 |
| Days to Decision | 221 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 |