PHILIPS ULTRASOUND P800 IMAGING SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

HEWLETT-PACKARD CO.

The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Philips Ultrasound P800 Imaging System.

Pre-market Notification Details

Device IDK935923
510k NumberK935923
Device Name:PHILIPS ULTRASOUND P800 IMAGING SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
ContactPaul Schrader
CorrespondentPaul Schrader
HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
Product CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-13
Decision Date1994-12-08

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