VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS

Coil, Magnetic Resonance, Specialty

SENTINELLE MEDICAL, INC.

The following data is part of a premarket notification filed by Sentinelle Medical, Inc. with the FDA for Vanguard Mri Auxiliary Patient Table With 4 And 8 Channel Coil Array For Ge Signa Systems.

Pre-market Notification Details

Device IDK060873
510k NumberK060873
Device Name:VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS
ClassificationCoil, Magnetic Resonance, Specialty
Applicant SENTINELLE MEDICAL, INC. 3080 YONGE STREET SUITE 6020 Toronto, Ontario,  CA M4n 3n1
ContactCameron Piron
CorrespondentDaniel W Lehtonen
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-03-30
Decision Date2006-04-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838084537 K060873 000
00884838081536 K060873 000
00884838081567 K060873 000
00884838081574 K060873 000
00884838081697 K060873 000
00884838081727 K060873 000
00884838081734 K060873 000
00884838083608 K060873 000
00884838083615 K060873 000
00884838080966 K060873 000

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