DAHLBERG MODEL US SPECTRUM IN-THE-EAR HEARING AID— 510(k) K852098
Substantially Equivalent for Some IndicationsMiracle-Ear/Dahlberg, Inc.
FDA 510(k) clearance K852098 for DAHLBERG MODEL US SPECTRUM IN-THE-EAR HEARING AID, Substantially Equivalent for Some Indications on 1985-08-16. Applicant: Miracle-Ear/Dahlberg, Inc.. Device class: 1.
Clearance details
- Applicant
- Miracle-Ear/Dahlberg, Inc.
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Golden Valley, MN, US
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