K781176

Substantially Equivalent

PATIENT AID, MODEL DM-351

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: FKQ
Advisory panel: Gastroenterology, Urology
Date received: 1978-07-12
Decision date: 1978-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code FKQ

product code FKQ

Other: 1
Total: 1

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.