DIGIFOCUS COMPACT— 510(k) K961059
Substantially EquivalentOticon, Inc.
FDA 510(k) clearance K961059 for DIGIFOCUS COMPACT, Substantially Equivalent on 1996-05-07. Applicant: Oticon, Inc.. Device class: 1.
Clearance details
- Applicant
- Oticon, 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
- Somerset, NJ, US
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