6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE

System, Imaging, Pulsed Echo, Ultrasonic

MEDISON AMERICA, INC.

The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for 6.5 Mhz Endorectal Convex Array (10r) Probe.

Pre-market Notification Details

Device IDK953773
510k NumberK953773
Device Name:6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant MEDISON AMERICA, INC. 5880 WEST LAS POSITAS BLVD., SUITE 52 Pleasanton,  CA  94566
ContactMark F Hayward
CorrespondentMark F Hayward
MEDISON AMERICA, INC. 5880 WEST LAS POSITAS BLVD., SUITE 52 Pleasanton,  CA  94566
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-14
Decision Date1996-03-14

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