ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID— 510(k) K910313
Substantially EquivalentOtotech, Ltd.
FDA 510(k) clearance K910313 for ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID, Substantially Equivalent on 1991-03-18. Applicant: Ototech, Ltd.. Device class: 1.
Clearance details
- Applicant
- Ototech, Ltd.
- 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
- Minneapolis, MN, US
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