FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
K Number: K023062
·
Decision Sep 30, 2002
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
6
Review Days
14
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Basic Information
- Device Name
- GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
- K Number
- K023062
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories, Inc.
- Date Received
- September 16, 2002
- Decision Date
- September 30, 2002
- 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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