The following data is part of a premarket notification filed by Care Essentials Pty Ltd with the FDA for Cocoon Convective Warming System.
| Device ID | K181671 |
| 510k Number | K181671 |
| Device Name: | Cocoon Convective Warming System |
| Classification | System, Thermal Regulating |
| Applicant | Care Essentials Pty Ltd 25 Slevin St North Geelong, AU 3215 |
| Contact | Abhay Sinha |
| Correspondent | Abhay Sinha Care Essentials Pty Ltd 25 Slevin St North Geelong, AU 3215 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-25 |
| Decision Date | 2019-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19332017000048 | K181671 | 000 |