데이터베이스 소개
국제 의료기기 데이터베이스 사용법
데이터 다운받기
FAQ
출처표기
Devices
SmartEP
모델명 / 제조번호(시리얼번호)
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.
의료기기 분류등급
Neurological Devices
의료기기 등급
2
이식된 장치?
No
유통
Nationwide distribution.
제품 설명
Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016
Manufacturer
Intelligent Hearing Systems Corp.
1 Event
SmartEP 의 리콜
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제조사
Intelligent Hearing Systems Corp.
제조사 주소
Intelligent Hearing Systems Corp., 6860 Sw 81st St, Miami FL 33143-7708
제조사 모회사 (2017)
Intelligent Hearing Systems Corp.
Source
USFDA
Language
English
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한국어