FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
FDA 510(k) clearance K133958 · decided 2014-03-20
Clearance details
- K-number
- K133958
- Device name
- FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
- Applicant
- Maquet Critical Care AB
- Decision
- Substantially Equivalent
- Date received
- 2013-12-24
- Decision date
- 2014-03-20
- Days to decision
- 86 days
- Clearance type
- Abbreviated
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Wayne, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Flow-i C20 Anesthesia System, model 6677200 recall (Z-0987-2024) | Getinge Usa Sales Inc | 2024-02-06 |
| Flow-i C30 Anesthesia System, model 6677300 recall (Z-0988-2024) | Getinge Usa Sales Inc | 2024-02-06 |
| Flow-i C40 Anesthesia System, model 6677400 recall (Z-0989-2024) | Getinge Usa Sales Inc | 2024-02-06 |
| Flow-c Anesthesia System, model 6887700 recall (Z-0990-2024) | Getinge Usa Sales Inc | 2024-02-06 |
| Flow-e Anesthesia System, model 6887900 recall (Z-0991-2024) | Getinge Usa Sales Inc | 2024-02-06 |
| Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is recall (Z-0804-2016) | Maquet Cardiovascular Us Sales, Llc | 2016-02-22 |
| The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 recall (Z-2083-2015) | Maquet Cardiovascular Us Sales, Llc | 2015-07-15 |
| FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering in recall (Z-1706-2015) | Maquet Cardiovascular Us Sales, Llc | 2015-06-08 |