Anesthesia System
Anesthesia System: 2 catalogue numbers listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Gas-Machine, Anesthesia. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Prunus Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | BSZ |
| Device type | Gas-Machine, Anesthesia |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5160 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K201957 |
| Record published | 2021-07-15 |
| Record revised | 2026-01-21 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A8 | In distribution | |
| A9 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| A9800 Anesthesia Workstation | Oricare Inc. | 22 |
| Analgesia GAS Mixer, Digital MDM Delivery System | Parker Hannifin Corp. | 12 |
| Aladin2 | Datex-Ohmeda, Inc. | 12 |
| Penlon | Penlon Ltd. | 7 |
| Analgesia GAS Mixer, MDM Delivery System | Parker Hannifin Corp. | 6 |
| Codonics SLS500i Operating Software | Codonics, Inc. | 4 |
| Codonics Safe Label System®(SLS) 500i Point of Care Station | Codonics, Inc. | 4 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 4 |
| Codonics Safe Label System®(SLS) 550i Point of Care Station – 144C | Codonics, Inc. | 3 |
| Aestiva | Datex-Ohmeda, Inc. | 2 |
| Aisys | Datex-Ohmeda, Inc. | 2 |
| Infinium Medical Inc. | Infinium Medical, Inc. | 2 |
Showing 12 of 293. All products under Gas-Machine, Anesthesia
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253330 | 2026-06-25 |
| K201957 | 2021-03-26 |
| K171311 | 2018-01-12 |
| K171292 | 2018-01-12 |
| K151954 | 2015-10-27 |
| K142552 | 2015-01-23 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mindray DS USA, Inc. | 510(k) number | 2025-10-20 | Class II | Device Design | Potential for anesthesia leakage. | 148 units |
| Mindray DS USA, Inc. | 510(k) number | 2025-10-20 | Class II | Device Design | Potential for anesthesia leakage. | 54 units |
| Mindray DS USA, Inc. | 510(k) number | 2024-07-22 | Class II | Nonconforming Material/Component | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms asso | 2 units |
| Mindray DS USA, Inc. | 510(k) number | 2024-07-22 | Class II | Nonconforming Material/Component | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms asso | 96 units |
| Mindray DS USA, Inc. | 510(k) number | 2024-07-22 | Class II | Nonconforming Material/Component | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms asso | 24 units |
| Mindray DS USA, Inc. | 510(k) number | 2024-07-22 | Class II | Nonconforming Material/Component | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms asso | 96 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.