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Panels › Ear, Nose, Throat › Product code EWO · Class 2

Audiometer

Regulation 874.1050

0510(k)s in 12 months (235 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
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Top companies in EWO

Company510(k)sRecalls
Maico Hearing Instruments, Inc.200
Grason-Stadler, Inc.120
Bio-Logic Systems Corp.90
Etymotic Research80
Otodynamics80
Tracor Instruments, Inc.70
American Electromedics Corp.60
Micro Audiometrics Corp.60
Beltone Electronics Corp.50
Madsen Electronics (Canada) , Ltd.50
DateFirm and productCodeLinked 510(k)
Nov 25, 2023PATH
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
Open, Classified		 EWOK133012
K213345
Nov 25, 2023PATH
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
Open, Classified		 EWOK133012
K213345
Nov 25, 2023PATH
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
Open, Classified		 EWOK133012
K213345
Nov 25, 2023PATH
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
Open, Classified		 EWOK133012
K213345
Nov 12, 2008Cardinal Health, Inc
GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric t
Terminated		 EWOK011135

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