K231604

Substantially Equivalent

Instrument Case

Applicant: Cochlear Americas
Product code: KCT
Advisory panel: General Hospital
Date received: 2023-06-01
Decision date: 2023-08-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Lone Tree, CO, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.