The following data is part of a premarket notification filed by Brain Cool Ab with the FDA for The Iqool System.
| Device ID | K162523 |
| 510k Number | K162523 |
| Device Name: | The IQool System |
| Classification | Hyperthermia Monitor |
| Applicant | BRAIN COOL AB SCHEELEVAGEN 2 MEDICON VILLAGE Medicon Village, SE Se-223 81 |
| Contact | Martin Waleij |
| Correspondent | Adam Harris TARGET HEALTH INC. 261 MADISON AVE New York, NY 10016 |
| Product Code | NZE |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-09 |
| Decision Date | 2017-05-03 |
| Summary: | summary |