K060458

Substantially Equivalent

MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR

Applicant: Langford IC Systems, Inc.
Product code: FEB
Advisory panel: Gastroenterology, Urology
Date received: 2006-02-22
Decision date: 2006-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Walpole, MA, US

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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.