ECT CARBON FIBER PALLET, MODIFICATION

Bed, Scanning, Nuclear

SIEMENS GAMMASONICS, INC.

The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Ect Carbon Fiber Pallet, Modification.

Pre-market Notification Details

Device IDK912481
510k NumberK912481
Device Name:ECT CARBON FIBER PALLET, MODIFICATION
ClassificationBed, Scanning, Nuclear
Applicant SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates,  IL  60195 -7372
ContactIrena M Krutulis
CorrespondentIrena M Krutulis
SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates,  IL  60195 -7372
Product CodeIYZ  
CFR Regulation Number892.1350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-23
Decision Date1991-08-02

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