The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Flow-i Anesthesia System C20, C30 & C40.
| Device ID | K133958 |
| 510k Number | K133958 |
| Device Name: | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 |
| Classification | Gas-machine, Anesthesia |
| Applicant | MAQUET CRITICAL CARE AB 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Contact | Lia Liebgold |
| Correspondent | Lia Liebgold MAQUET CRITICAL CARE AB 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-24 |
| Decision Date | 2014-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07325710004128 | K133958 | 000 |
| 07325710001172 | K133958 | 000 |
| 07325710001141 | K133958 | 000 |
| 07325710001134 | K133958 | 000 |
| 07325710000458 | K133958 | 000 |
| 07325710000397 | K133958 | 000 |
| 07325710000212 | K133958 | 000 |
| 07325710004098 | K133958 | 000 |
| 17325710003487 | K133958 | 000 |
| 17325710003463 | K133958 | 000 |
| 07325710001196 | K133958 | 000 |
| 07325710001318 | K133958 | 000 |
| 07325710004104 | K133958 | 000 |
| 07325710003091 | K133958 | 000 |
| 17325710002510 | K133958 | 000 |
| 07325710001912 | K133958 | 000 |
| 07325710001813 | K133958 | 000 |
| 07325710001530 | K133958 | 000 |
| 07325710001363 | K133958 | 000 |
| 07325710001349 | K133958 | 000 |
| 07325710001325 | K133958 | 000 |
| 17325710003166 | K133958 | 000 |