UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID— 510(k) K946323
Substantially EquivalentUnitron Industries, Inc.
FDA 510(k) clearance K946323 for UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID, Substantially Equivalent on 1995-01-30. Applicant: Unitron Industries, Inc.. Device class: 1.
Clearance details
- Applicant
- Unitron Industries, 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
- Port Huron, MI, US
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