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INTELLIGENT HEARING SYSTEMS

SMARTEP · Gastroenterology and Urology

510(k): 3 Recall: 1 UDI: 2 MAUDE: 0 Class.: 10

510(k) Clearances (3)

SmartEP

2017-09-29

Substantially Equivalent

SMARTEP, MODEL M010000

2007-07-18

Substantially Equivalent

SMARTEP-ASSR, MODEL M811007

2004-02-20

Substantially Equivalent

Recalls (1)

Intelligent Hearing Systems Corporation, SmartEP with Vestibular Evoked Myogenic Potentials Version 3.96. Model M811016

2008-10-21

This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification application must be submitted and cleared in order to market and sell devices with Vestibular Evoked Myogenic Potential (VEMP) specific functions. The Food and Drug Administration considers that the VEMP testing functions

UDI Registrations (2)

SmartEP Software

SmartEP-ASSR Software

FDA Classification (10)

Device, Paste-On For Incontinence, Non-Sterile

Gastroenterology, Urology

String And Tubes, Gastrointestinal, To Locate Internal Bleeding

Gastroenterology, Urology

Plate, Patient

Gastroenterology, Urology

Dialyzer, Parallel Flow

Gastroenterology, Urology

Monitor, Esophageal Motility, Anorectal Motility, And Tube

Gastroenterology, Urology

Instrument, Biopsy, Mechanical, Gastrointestinal

Gastroenterology, Urology

Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs

Gastroenterology, Urology

Scoop

Gastroenterology, Urology

Hemodialyzer, Re-Use, High Flux

Gastroenterology, Urology

Cord, Electric, For Endoscope

Gastroenterology, Urology