The following data is part of a premarket notification filed by Tni Medical Ag with the FDA for Tni Softflow 50.
| Device ID | K180474 |
| 510k Number | K180474 |
| Device Name: | TNI SoftFlow 50 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | TNI Medical AG Hofmannstr. 8 Wuerzburg, DE 97084 |
| Contact | Joseph P. Mcmenamin |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-02-22 |
| Decision Date | 2018-10-18 |