K180788 is an FDA 510(k) clearance for the Gas Module 3. This device is classified as a Spirometer, Monitoring (w/wo Alarm) (Class II - Special Controls, product code BZK).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 24, 2018, 212 days after receiving the submission on March 26, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1850.
| 510(k) Number | K180788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2018 |
| Decision Date | October 24, 2018 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZK — Spirometer, Monitoring (w/wo Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1850 |