Elitone Device— 510(k) K183585
Substantially EquivalentElidah, Inc.
FDA 510(k) clearance K183585 for Elitone Device, Substantially Equivalent on 2019-02-11. Applicant: Elidah, Inc.. Device class: 2.
Clearance details
- Applicant
- Elidah, Inc.
- Product code
- Code QAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5330
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monroe, CT, US
Recent devices under product code QAJ
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