FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)
K Number: K940446
·
Decision Aug 15, 1994
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
9
Review Days
195
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Basic Information
- Device Name
- 3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)
- K Number
- K940446
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Minnesota Mining and Mfg. Co.
- Date Received
- February 1, 1994
- Decision Date
- August 15, 1994
- 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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| K954900 | 3M RED DOT ECG LEAD WIRES A | Jul 15, 1996 | Substantially Equivalent |
| K837117 | 3M FERLIC CHEST FILTER, X-RAY COMPENSATING FILTER | Mar 9, 1983 | Substantially Equivalent |