AMP 80/2 OUTFLOW MONITOR MODIFICATION— 510(k) K823827

Substantially Equivalent

American Medical Products, Inc.

FDA 510(k) clearance K823827 for AMP 80/2 OUTFLOW MONITOR MODIFICATION, Substantially Equivalent on 1983-03-17. Applicant: American Medical Products, Inc..

Clearance details

Applicant: American Medical Products, Inc.
Product code: Code FKX
Advisory panel: Gastroenterology, Urology
Date received: 1982-12-20
Decision date: 1983-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FKX

product code FKX

Death: 501
Injury: 6,720
Malfunction: 18,508
Other: 1
Total: 25,730

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.