510(k) K181671
K181671 is an FDA 510(k) premarket notification submitted by Care Essentials Pty, Ltd. for the device "Cocoon Convective Warming System". The FDA issued a decision of Substantially Equivalent on May 2, 2019. The device falls under product code DWJ (System, Thermal Regulating), a Class II device regulated under 21 CFR 870.5900. Care Essentials Pty, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2019
- Date Received
- June 25, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Thermal Regulating
- Device Class
- Class II
- Regulation Number
- 870.5900
- Review Panel
- CV
- Submission Type
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).