KLW

Product Code: KLW


Products Classified as KLW

1581Masker, TinnitusTinnitus Masker.

Total Product Life Cycle (TPLC) Devices

1581Masker, TinnitusTinnitus Masker.

FDA Consensus Standards

Masker, Tinnitus [31251]21 CFR §874.3400 🔎
Masker, Tinnitus [32302]21 CFR §874.3400 🔎
Masker, Tinnitus [29591]21 CFR §874.3400 🔎
Masker, Tinnitus [33856]21 CFR §874.3400 🔎
Masker, Tinnitus [38629]21 CFR §874.3400 🔎
Masker, Tinnitus [29583]21 CFR §874.3400 🔎

Pre-market Notifications for KLW

K201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc.
K193303Tinnitus Sound Generator ModuleGN Hearing A/S
K181586Tinnitus Sound Generator ModuleGN Hearing A/S
K180495Tinnitus Sound Generator ModuleGN Hearing A/S
K171243Audifon Tinnitus-ModuleAudiofon USA Inc.
K163094TinniLogic Mobile Tinnitus Management DeviceJIANGSU BETTERLIFE MEDICAL CO., LTD.
K161562Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments Inc.
K161331HyperSound Tinnitus ModuleTURTLE BEACH CORPORATION
K151719REVE134KW EAR LAB, INC
K151558Desyncra For Tinnitus Therapy System, Desyncra For Tinnitus Pro SystemNEUROTHERAPIES RESET GMBH.
K150171Tinnitus Sound Generator ModuleGN RESOUND A/S
K150065SoundCure Serenade Tinnitus Treatment SystemSoundCure, Inc.
K150014SerenitySANUTHERA, INC.
K140845LEVO TINNITUS MASKING SOFTWARE DEVICEOTOHARMONICS CORP
K133308TINNITUS SOUNDSUPPORTOTICON A/S

Global Unique Device Identification Database

00627843723226Masker, Tinnitus
00089518000801Masker, Tinnitus
00089518000795Masker, Tinnitus
00089518000788Masker, Tinnitus
00089518000771Masker, Tinnitus
00089518000764Masker, Tinnitus
00089518000757Masker, Tinnitus
00089518000740Masker, Tinnitus
00089518000733Masker, Tinnitus
00089518000726Masker, Tinnitus
00089518000719Masker, Tinnitus
00089518000702Masker, Tinnitus
00089518000696Masker, Tinnitus
00089518000689Masker, Tinnitus
00089518000672Masker, Tinnitus

Maude Adverse Events

NEUROMONICS OASIS TINNITUS DEVICENEUROMONICS INC2015-07-17
PHONAK "HEARING AID MASKERS"PHONAK2015-06-30
NEUROMONITCS OASIS.NEUROMONICS, INC.2015-02-27
NEUROMONICS OASISNEUROMONICS INC.2015-02-20
NEUROMONICS OASIS TINNITUS TREATMENTNEUROMONICS2012-11-06
GNRESOUNDGNRESOUND2011-05-12
NEUROMONICS OASISNEUROMONICS2010-05-16
NEUROMONICS OASIS TINNITUS TREATMENT DEVICENEUROMONICS INC.2009-02-03
NEUROMONICS TINNITUS TREATMENTNEUROMONICS INC.2007-08-16
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