AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC— 510(k) K971399
Substantially EquivalentGeneral Hearing Instruments, Inc.
FDA 510(k) clearance K971399 for AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC, Substantially Equivalent on 1997-06-13. Applicant: General Hearing Instruments, Inc.. Device class: 1.
Clearance details
- Applicant
- General Hearing Instruments, 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
- Harahan, LA, US
Recent devices under product code ESD
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