The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Maquet Flow-i C20, Maquet Flow-i C30, Maquet Flow-i C40.
| Device ID | K112114 |
| 510k Number | K112114 |
| Device Name: | MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 |
| Classification | Gas-machine, Anesthesia |
| Applicant | MAQUET CRITICAL CARE AB 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Contact | Whitney Torning |
| Correspondent | Whitney Torning MAQUET CRITICAL CARE AB 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-25 |
| Decision Date | 2012-01-13 |
| Summary: | summary |