FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
Cocoon Convective Warming System
K Number: K181671
·
Decision May 2, 2019
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
154
Applicant Total
3
Review Days
311
Basic Information
- Device Name
- Cocoon Convective Warming System
- K Number
- K181671
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Care Essentials Pty Ltd
- Date Received
- June 25, 2018
- Decision Date
- May 2, 2019
- Product Code
- DWJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWJ | System, Thermal Regulating | FDA class 2 | Cardiovascular |
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