510(k) K112114
K112114 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40". The FDA issued a decision of Substantially Equivalent on January 13, 2012. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Maquet Critical Care AB has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2012
- Date Received
- July 25, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas-Machine, Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5160
- Review Panel
- AN
- Submission Type