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Manufacturers
Intelligent Hearing Systems Corp.
Manufacturer Address
Intelligent Hearing Systems Corp., 6860 Sw 81st St, Miami FL 33143-7708
Manufacturer Parent Company (2017)
Intelligent Hearing Systems Corp.
Source
USFDA
1 Event
Recall of SmartEP
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One device in the database
SmartEP
Model / Serial
IHS2195, IHS3048V, IHS3116, IHS3128V, IHS3182, IHS3420, IHS3431, IHS3443, IHS3485, IHS3545, IHS3563, IHS3565, IHS3580, IHS3591, IHS3642, IHS3665, IHS3668, IHS3683, IHS3829, IHS3878, IHS3967, IHS4001, IHS2209, IHS2281, IHS3110, IHS3324, IHS3410, IHS3426, IHS3460, IHS3542, IHS3548, IHS3623, IHS3638, IHS3787, IHS3961, IHS3011, IHS3387, IHS3429, IHS3432, IHS3494, IHS3593, IHS3619, IHS3704, IHS2184, IHS3008, IHS3248, IHS3314, IHS3819, IHS3893, IHS4040.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution.
Product Description
Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016
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