Instrument Case— 510(k) K231604
Substantially EquivalentCochlear Americas
FDA 510(k) clearance K231604 for Instrument Case, Substantially Equivalent on 2023-08-24. Applicant: Cochlear Americas. Device class: 2.
Clearance details
- Applicant
- Cochlear Americas
- Product code
- Code KCT
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lone Tree, CO, US
Recent devices under product code KCT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.