MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
FDA 510(k) clearance K112114 · decided 2012-01-13
Clearance details
- K-number
- K112114
- Device name
- MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
- Applicant
- Maquet Critical Care AB
- Decision
- Substantially Equivalent
- Date received
- 2011-07-25
- Decision date
- 2012-01-13
- Days to decision
- 172 days
- Clearance type
- Traditional
- 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
+ Add to Predicate Builder ◉ Watch Maquet Critical Care AB
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while recall (Z-1925-2012) | Maquet Cardiovascular Us Sales, Llc | 2012-07-06 |