FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO STRYKER PAINPUMP2
K Number: K030885
·
Decision Apr 18, 2003
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
844
Applicant Total
54
Review Days
28
Basic Information
- Device Name
- MODIFICATION TO STRYKER PAINPUMP2
- K Number
- K030885
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STRYKER INSTRUMENTS
- Date Received
- March 21, 2003
- Decision Date
- April 18, 2003
- 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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