FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUFUSER; ACCUFUSER PLUS
K Number: K003915
·
Decision Feb 15, 2001
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
87
Applicant Total
4
Review Days
58
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Basic Information
- Device Name
- ACCUFUSER; ACCUFUSER PLUS
- K Number
- K003915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Help Technologies
- Date Received
- December 19, 2000
- Decision Date
- February 15, 2001
- Product Code
- MEB
- 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 |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | FDA class 2 | General Hospital |
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