FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL
K Number: K083336
·
Decision Jun 3, 2009
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
154
Applicant Total
38
Review Days
203
Basic Information
- Device Name
- LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL
- K Number
- K083336
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SMITHS MEDICAL ASD, INC.
- Date Received
- November 12, 2008
- Decision Date
- June 3, 2009
- 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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