K181671 is an FDA 510(k) clearance for the Cocoon Convective Warming System. This device is classified as a System, Thermal Regulating (Class II - Special Controls, product code DWJ).
Submitted by Care Essentials Pty, Ltd. (North Geelong, AU). The FDA issued a Cleared decision on May 2, 2019, 311 days after receiving the submission on June 25, 2018.
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 | K181671 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2018 |
| Decision Date | May 02, 2019 |
| Days to Decision | 311 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| 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). |