Hearing Healthcare Pro— 510(k) K183201
Substantially EquivalentDb Diagnostic Systems, Inc.
FDA 510(k) clearance K183201 for Hearing Healthcare Pro, Substantially Equivalent on 2019-03-06. Applicant: Db Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Db Diagnostic Systems, Inc.
- Product code
- Code ETY
- Device class
- Class 2
- Regulation
- 21 CFR 874.1090
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Weston, CT, US
Recent devices under product code ETY
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