Identity
- Trade Name
- Otomag™ Alpha 2 Sound Processor FDA UDI
- Generic Name
- Bone-conduction hearing aid, head-worn FDA UDI
- Device Name
- PROCESSOR S0415-01 ALPHA2MPO CH MRI UNSF FDA UDI
- Model / Reference
- S0415-01 FDA UDI
- Description
- PROCESSOR S0415-01 ALPHA2MPO CH MRI UNSF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169645271 FDA UDI
- 510(k) Number
- K100193 FDA UDI
- FDA Product Code
- LXB FDA UDI
- GMDN Term
- Bone-conduction hearing aid, head-worn FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3302 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Bone-conduction hearing aid, head-worn
Otomag™ Alpha 2 Sound Processor by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-conduction hearing aid, head-worn.
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- ADHEAR User Kit, Simply Black — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- ADHEAR Audio Processor, Model 701, Test Device — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- ADHEAR Audio Processor, Model 701, Dove Silver — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- ADHEAR Audio Processor, Model 701, Simply Black — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- ADHEAR User Kit, Terra Brown — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- ADHEAR Audio Processor (701), Terra Brown, lock — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
- ADHEAR Audio Processor (701), Dove Silver, lock — Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Class II
Cleared under the same submission
K100193 also covers:
- Otomag™ Alpha 2 Sound Processor — MEDTRONIC XOMED, INC.
- Otomag™ Alpha 2 Sound Processor — MEDTRONIC XOMED, INC.
- Otomag™ Alpha 2 Sound Processor — MEDTRONIC XOMED, INC.
- Otomag™ Alpha 2 Sound Processor — MEDTRONIC XOMED, INC.
- Otomag™ Alpha 2 Sound Processor — MEDTRONIC XOMED, INC.
- Otomag™ Alpha 2 Sound Processor — MEDTRONIC XOMED, INC.
- Otomag™ Alpha 2 Sound Processor — MEDTRONIC XOMED, INC.
- Otomag™ Alpha 2 Sound Processor — MEDTRONIC XOMED, INC.
- Otomag™ Alpha 2 Sound Processor — MEDTRONIC XOMED, INC.
- Otomag™ Alpha 2 Sound Processor — MEDTRONIC XOMED, INC.
- Otomag™ Alpha 2 Sound Processor — MEDTRONIC XOMED, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI c628f0d2-2640-42d6-99a5-3784770ec319 36 fields · synced May 30, 2026