FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRATOFUSE PCA II INFUSER
K Number: K941151
·
Decision Jul 7, 1994
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
3
Review Days
118
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Basic Information
- Device Name
- STRATOFUSE PCA II INFUSER
- K Number
- K941151
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Infusion Technology Intl.
- Date Received
- March 11, 1994
- Decision Date
- July 7, 1994
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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