AIRIS II

Coil, Magnetic Resonance, Specialty

HITACHI MEDICAL SYSTEMS AMERICA, INC.

The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Airis Ii.

Pre-market Notification Details

Device IDK994378
510k NumberK994378
Device Name:AIRIS II
ClassificationCoil, Magnetic Resonance, Specialty
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
ContactDouglas J Thistlethwaite
CorrespondentDouglas J Thistlethwaite
HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-27
Decision Date2000-03-07
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.