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
FRN Pump, Infusion

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