Submission Details
| 510(k) Number | K180788 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Gas Module 3
Oct 2018
Decision
212d
Days
Class 2
Risk
About This 510(k) Submission
K180788 is an FDA 510(k) clearance for the Gas Module 3, 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 review panel. Regulated under 21 CFR 868.1850.
Device Classification
| Product Code | BZK — Spirometer, Monitoring (w/wo Alarm) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.1850 |
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Shenzhen · CN
Yanhong Bai
154 submissions
154 cleared
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