FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
MODEL 1200 ABMULATORY INFUSION PUMP
K Number: K961263
·
Decision Aug 23, 1996
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
5
Review Days
143
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Basic Information
- Device Name
- MODEL 1200 ABMULATORY INFUSION PUMP
- K Number
- K961263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Patient Solutions, Inc.
- Date Received
- April 2, 1996
- Decision Date
- August 23, 1996
- 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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Other Clearances by Patient Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964384 | MODEL D-290P ADMINISTRATION SET | Jan 27, 1997 | Substantially Equivalent |
| 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 |