TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05— 510(k) K971296
Substantially EquivalentNational Hearing Aid Dist., Inc.
FDA 510(k) clearance K971296 for TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05, Substantially Equivalent on 1997-06-20. Applicant: National Hearing Aid Dist., Inc.. Device class: 1.
Clearance details
- Applicant
- National Hearing Aid Dist., 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
- Scarborough, ME, US
Recent devices under product code ESD
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