INFUSION DYNAMICS POWER INFUSER MODEL M100B— 510(k) K992044

Substantially Equivalent

Infusion Dynamics, Inc.

FDA 510(k) clearance K992044 for INFUSION DYNAMICS POWER INFUSER MODEL M100B, Substantially Equivalent on 1999-09-08. Applicant: Infusion Dynamics, Inc..

Clearance details

Applicant: Infusion Dynamics, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1999-06-17
Decision date: 1999-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View 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, 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.