Fischer-Zoth Diagnosesystemne GmbH / DEKRA Certification GmbH / Natus Europe GmbH / EMC / /
Continent
Europe / /
Country
Germany / United States / Netherlands / Italy / Canada / /
Facility
esimaton)University Medical Center / station Ear Probe / University Mainz / ENT Clinic / University of Ferrara / /
IndustryTerm
regular audits / handheld device / signal processing information / memory chip / test protocol / portable device / simulator device / respective predicate devices / predicate devices / online information / diagnostic protocols / technology standards / predicate device / handheld devices / diagnostic features based on sophisticated algorithms / stationary device / electrical systems / respective predicate device / /
Organization
University of Ferrara / FDA / University Medical Center of the Johannesetmio / Stavrous Hatzopoulos AccuScreen Department of Audiology and Speech Therapy / /
Person
Hans Peter Niedermeyer / Landsberger Str / Isar Technish / Isar Technische / Thomas Rosner / / /
Position
Director / bone conductor / General / licensed physician / /
JUN[removed]K-1 S3[removed]k) Summary SUBMISSION INFORMATION Date of preparation: