OMNI 2000 SERIES ITE HEARING AID— 510(k) K934416
Substantially EquivalentStarkey Laboratories, Inc.
FDA 510(k) clearance K934416 for OMNI 2000 SERIES ITE HEARING AID, Substantially Equivalent on 1993-11-29. Applicant: Starkey Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Starkey Laboratories, 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
- Eden Prairie, MN, US
Recent devices under product code ESD
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