PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL

System, Nuclear Magnetic Resonance Imaging

MEDICAL ADVANCES, INC.

The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Phased Array Shoulder Coil, Quadrature Shoulder Coil.

Pre-market Notification Details

Device IDK945778
510k NumberK945778
Device Name:PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee,  WI  53226
ContactThomas E Tynes
CorrespondentThomas E Tynes
MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee,  WI  53226
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-25
Decision Date1995-03-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838066366 K945778 000
00884838065710 K945778 000

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