The following data is part of a premarket notification filed by Mc3 Incorporated with the FDA for Nautilus Smart Ecmo Module.
| Device ID | K191935 |
| 510k Number | K191935 |
| Device Name: | Nautilus Smart ECMO Module |
| Classification | Oxygenator, Long Term Support Greater Than 6 Hours |
| Applicant | MC3 Incorporated 2555 Bishop Circle W Dexter, MI 48130 |
| Contact | Adam Viitala |
| Correspondent | Martha Rumford MC3 Incorporated 2555 Bishop Circle W Dexter, MI 48130 |
| Product Code | BYS |
| CFR Regulation Number | 870.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-19 |
| Decision Date | 2020-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854916006888 | K191935 | 000 |
| 10854916006871 | K191935 | 000 |
| 10850007732087 | K191935 | 000 |
| 10850007732032 | K191935 | 000 |
| 10854916006987 | K191935 | 000 |
| 20854916006908 | K191935 | 000 |
| 20854916006892 | K191935 | 000 |