510(k) K112114

MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 by Maquet Critical Care AB — Product Code BSZ

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