FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
PATIENT CONTROLLED SYRINGE PUMP TYPE 3300
K Number: K915270
·
Decision Aug 24, 1992
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
30
Applicant Total
5
Review Days
273
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Basic Information
- Device Name
- PATIENT CONTROLLED SYRINGE PUMP TYPE 3300
- K Number
- K915270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Graseby Medical , Ltd.
- Date Received
- November 25, 1991
- Decision Date
- August 24, 1992
- Product Code
- MEA
- 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 |
|---|---|---|---|
| MEA | Pump, Infusion, Pca | FDA class 2 | General Hospital |
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Other Clearances by Graseby Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K944721 | 9000 INFUSION PUMP | Aug 11, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K931318 | 3400 INFUSION PUMP | Dec 9, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K912192 | 3100 INFUSION PUMP | Feb 14, 1992 | Substantially Equivalent |
| K912193 | 3000 INFUSION PUMP | Feb 14, 1992 | Substantially Equivalent |