MIRACLE-EAR DIGITAL BTE— 510(k) K972344
Substantially EquivalentMiracle-Ear, Inc.
FDA 510(k) clearance K972344 for MIRACLE-EAR DIGITAL BTE, Substantially Equivalent on 1997-07-23. Applicant: Miracle-Ear, Inc.. Device class: 1.
Clearance details
- Applicant
- Miracle-Ear, 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
- Clearance type
- Traditional
- Location
- Golden Valley, MN, US
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