The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System.
| Device ID | K191027 |
| 510k Number | K191027 |
| Device Name: | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System |
| Classification | Gas-machine, Anesthesia |
| Applicant | Maquet Critical Care AB Rontgenvagen 2 Solna, SE 17154 |
| Contact | Kribu Valdre |
| Correspondent | Mark N. Smith Getinge 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 | 2019-04-18 |
| Decision Date | 2020-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07325710012420 | K191027 | 000 |
| 07325710008416 | K191027 | 000 |
| 07325710008423 | K191027 | 000 |
| 07325710008430 | K191027 | 000 |
| 07325710009642 | K191027 | 000 |
| 07325710009789 | K191027 | 000 |
| 07325710009819 | K191027 | 000 |
| 07325710009864 | K191027 | 000 |
| 07325710009871 | K191027 | 000 |
| 07325710009888 | K191027 | 000 |
| 07325710009895 | K191027 | 000 |
| 07325710010457 | K191027 | 000 |
| 07325710010464 | K191027 | 000 |
| 07325710010617 | K191027 | 000 |
| 07325710010624 | K191027 | 000 |
| 07325710010631 | K191027 | 000 |
| 07325710010860 | K191027 | 000 |
| 07325710008409 | K191027 | 000 |