ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL

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 (emmission Computed Tomography) Carbon Fib Pal.

Pre-market Notification Details

Device IDK903767
510k NumberK903767
Device Name:ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL
ClassificationBed, Scanning, Nuclear
Applicant SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates,  IL  60195 -7372
ContactDennis W Henkelman
CorrespondentDennis W Henkelman
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 Received1990-08-20
Decision Date1990-09-07

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