The following data is part of a premarket notification filed by Plastiflex Group Nv with the FDA for Hybernite Rt.
| Device ID | K151461 |
| 510k Number | K151461 |
| Device Name: | Hybernite RT |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | PLASTIFLEX GROUP NV BEVERLOOSESTEENWEG 99 Paal-beringen, BE 3583 |
| Contact | Raf Van Roy |
| Correspondent | Patsy J Trisler Qserve Group US, Inc. PO BOX 940 Charlestown, NH 03603 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-01 |
| Decision Date | 2016-03-24 |
| Summary: | summary |