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

Name: FDA 510(k) clearance K940446
Creator: U.S. Food and Drug Administration
Published: 1994-08-15

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.. Device class: 2.

Clearance details

Applicant: Minnesota Mining and Mfg. Co.
Product code: Code FRN
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1994-02-01
Decision date: 1994-08-15
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: St. Paul, MN, US

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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, 2020-01-01 through 2026-04-23. 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.