FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL D-290P ADMINISTRATION SET
K Number: K964384
·
Decision Jan 27, 1997
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
5
Review Days
84
Basic Information
- Device Name
- MODEL D-290P ADMINISTRATION SET
- K Number
- K964384
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PATIENT SOLUTIONS, INC.
- Date Received
- November 4, 1996
- Decision Date
- January 27, 1997
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by PATIENT SOLUTIONS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K961263 | MODEL 1200 ABMULATORY INFUSION PUMP | Aug 23, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K954841 | MODEL D-285N ADMINISTRATION SET | Dec 11, 1995 | Substantially Equivalent |
| K953270 | MODEL 1100 MEDMATE INFUSION PUMP | Oct 7, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K894028 | AMBULATORY INFUSION SYSTEM AND ACCESSORIES | Dec 22, 1989 | Substantially Equivalent |