FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY
K Number: K141686
·
Decision Oct 28, 2014
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
157
Applicant Total
1
Review Days
127
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Basic Information
- Device Name
- EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY
- K Number
- K141686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith Medical Asd, Inc.
- Date Received
- June 23, 2014
- Decision Date
- October 28, 2014
- 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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