A8, A9 Anesthesia System
FDA 510(k) clearance K201957 · decided 2021-03-26
Clearance details
- K-number
- K201957
- Device name
- A8, A9 Anesthesia System
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-14
- Decision date
- 2021-03-26
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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