PERCUNAV SYSTEM

System, X-ray, Tomography, Computed

PHILIPS HEALTHCARE

The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Percunav System.

Pre-market Notification Details

Device IDK132087
510k NumberK132087
Device Name:PERCUNAV SYSTEM
ClassificationSystem, X-ray, Tomography, Computed
Applicant PHILIPS HEALTHCARE 49 SPADINA AVENUE #310 Toronto,  CA M5v 2j1
ContactDave Szczupakowski
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeJAK  
Subsequent Product CodeIYO
Subsequent Product CodeLLZ
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2013-07-05
Decision Date2013-07-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838083059 K132087 000
00884838068629 K132087 000
00884838068636 K132087 000
00884838068643 K132087 000
00884838081239 K132087 000
00884838081253 K132087 000
00884838082960 K132087 000
00884838082984 K132087 000
00884838082991 K132087 000
00884838083004 K132087 000
00884838083011 K132087 000
00884838083028 K132087 000
00884838083035 K132087 000
00884838083042 K132087 000
00884838068605 K132087 000

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