MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS

Coil, Magnetic Resonance, Specialty

INVIVO CORPORATION

The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Models Hrs-63-8 And Hrs-127-8 Shoulder Array Coils.

Pre-market Notification Details

Device IDK053017
510k NumberK053017
Device Name:MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
ClassificationCoil, Magnetic Resonance, Specialty
Applicant INVIVO CORPORATION N27 W23676 PAUL RD. Pewaukee,  WI  53072
ContactThomas Schubert
CorrespondentThomas Schubert
INVIVO CORPORATION N27 W23676 PAUL RD. Pewaukee,  WI  53072
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-26
Decision Date2005-11-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838086296 K053017 000
00884838086234 K053017 000
00884838067387 K053017 000
00884838067318 K053017 000
00884838066687 K053017 000
00884838066472 K053017 000
00884838066465 K053017 000
00884838066236 K053017 000
00884838088535 K053017 000

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