|
Device |
masker, tinnitus |
Product Code | KLW |
Regulation Number |
874.3400
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AMPLISOUND HEARING PRODUCTS & SERVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANM ADAPTIVE NEUROMODULATION GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AUDIFON GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AUDIFON-USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
1. K083488 JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
|
2. K130417 AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO ...
|
3. K130514 AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDI ...
|
AUDIOFON USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AURELIYM GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DUEARITY AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GN HEARING A/S |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GN RESOUND A/S |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GOLDENEAR COMPANY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANSATON AKUSTIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU BETTERLIFE MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KW EAR LAB, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUROTHERAPIES RESET GMBH. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OTICON A/S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OTOHARMONICS CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHONAK LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PNQ HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SANUTHERA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUND OPTIONS TINNITUS TREATMENTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUNDCURE INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUNDCURE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STARKEY LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STARKEY LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TURTLE BEACH CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITRON HEARING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WIDEX USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
MDR Year |
MDR Reports |
MDR Events |
2015 |
4 |
4 |
|
|
|
|