The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Flow-i Anesthesia System C20, Flow-i Anesthesia System C30, Flow-i Anesthesia System C40.
| Device ID | K160665 |
| 510k Number | K160665 |
| Device Name: | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 |
| Classification | Gas-machine, Anesthesia |
| Applicant | MAQUET CRITICAL CARE AB RONTGENVAGEN 2 Solna, SE Se-171 54 |
| Contact | Carina Lundberg |
| Correspondent | Mark Dinger MAQUET MEDICAL SYSTEMS USA 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 | 2016-03-09 |
| Decision Date | 2017-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07325710009604 | K160665 | 000 |