K232844 is an FDA 510(k) clearance for the The IQoolTM System. This device is classified as a System, Thermal Regulating (Class II - Special Controls, product code DWJ).
Submitted by Braincool AB (Lund, SE). The FDA issued a Cleared decision on October 4, 2023, 20 days after receiving the submission on September 14, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5900. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K232844 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2023 |
| Decision Date | October 04, 2023 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWJ — System, Thermal Regulating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5900 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |