The following data is part of a premarket notification filed by Seiratherm Gmbh with the FDA for Tempedy.
| Device ID | K152946 |
| 510k Number | K152946 |
| Device Name: | TEMPEDY |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | SEIRATHERM GMBH BEETHOVEN STREET. 10 91074 Herzogenaurach, DE 13033 |
| Contact | Matthias Roth |
| Correspondent | Mike Johnson PHILOSOPHER'S RIVER LLC PO BOX 106 Willow Creek, MT 59760 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-06 |
| Decision Date | 2016-09-15 |
| Summary: | summary |