FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDI BUTLER
K Number: K051324
·
Decision Dec 5, 2005
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
63
Applicant Total
4
Review Days
199
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Basic Information
- Device Name
- MEDI BUTLER
- K Number
- K051324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5780
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medi USA, LP
- Date Received
- May 20, 2005
- Decision Date
- December 5, 2005
- Product Code
- DWL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | FDA class 2 | General Hospital |
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