3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION)— 510(k) K940446

Substantially Equivalent - Subject to Tracking Reg.

Minnesota Mining and Mfg. Co.

FDA 510(k) clearance K940446 for 3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION), Substantially Equivalent - Subject to Tracking Reg. on 1994-08-15. Applicant: Minnesota Mining and Mfg. Co..

Clearance details

Applicant
Minnesota Mining and Mfg. Co.
Product code
Code FRN
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent - Subject to Tracking Reg.
Clearance type
Traditional
Location
St. Paul, MN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FRN

product code FRN
Death
540
Injury
6,178
Malfunction
1,464,165
Other
52
Total
1,470,935

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.