7.5 MHZ ENDORECTAL PROBE

System, Imaging, Pulsed Echo, Ultrasonic

PHILIPS ULTRASOUND, INC.

The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for 7.5 Mhz Endorectal Probe.

Pre-market Notification Details

Device IDK881028
510k NumberK881028
Device Name:7.5 MHZ ENDORECTAL PROBE
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant PHILIPS ULTRASOUND, INC. 2722 S. FAIRVIEW Santa Ana,  CA  92704
ContactMartin A Kaufman
CorrespondentMartin A Kaufman
PHILIPS ULTRASOUND, INC. 2722 S. FAIRVIEW Santa Ana,  CA  92704
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-10
Decision Date1988-04-27

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