FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)
K Number: K093332
·
Decision Dec 9, 2009
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
844
Applicant Total
2
Review Days
44
Basic Information
- Device Name
- DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)
- K Number
- K093332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DELPHI MEDICAL SYSTEMS
- Date Received
- October 26, 2009
- Decision Date
- December 9, 2009
- Product Code
- FRN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
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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Other Clearances by DELPHI MEDICAL SYSTEMS
| K Number | Device Name | ||
|---|---|---|---|
| K073242 | PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 | Jan 3, 2008 | Substantially Equivalent |