AMBULATORY MARK XI DRUG INFUSION DEV-— 510(k) K830657

Substantially Equivalent

Windsor Medical, Inc.

FDA 510(k) clearance K830657 for AMBULATORY MARK XI DRUG INFUSION DEV-, Substantially Equivalent on 1983-09-16. Applicant: Windsor Medical, Inc..

Clearance details

Applicant: Windsor Medical, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1983-03-02
Decision date: 1983-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.