Instrument Case P1340904— 510(k) K223672

Substantially Equivalent

Cochlear

FDA 510(k) clearance K223672 for Instrument Case P1340904, Substantially Equivalent on 2023-03-21. Applicant: Cochlear. Device class: 2.

Clearance details

Applicant: Cochlear
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2022-12-07
Decision date: 2023-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lone Tree, CO, US

Download summary PDF View on FDA.gov ↗

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