Submission Details
| 510(k) Number | K171292 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 02, 2017 |
| Decision Date | January 12, 2018 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
A7 Anesthesia System
Jan 2018
Decision
255d
Days
Class 2
Risk
About This 510(k) Submission
K171292 is an FDA 510(k) clearance for the A7 Anesthesia System, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Nanshan Shenzhen, CN). The FDA issued a Cleared decision on January 12, 2018, 255 days after receiving the submission on May 2, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.
Device Classification
| Product Code | BSZ — Gas-machine, Anesthesia |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5160 |
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Nanshan Shenzhen · CN
Yanhong Bai
154 submissions
154 cleared
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