510(k) K936178— AGILANCE-GOLDEN SPOONS

Substantially Equivalent for Some Indications

Oismuller & Partner Keg

Clearance details

Applicant: Oismuller & Partner Keg
Product code: Code ISA
Advisory panel: Physical Medicine
Date received: 1993-12-27
Decision date: 1995-01-18
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Austria, AT

Adverse events under product code ISA

product code ISA

Death: 3
Other: 1
Total: 4

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.