CARDIAC SPECT PALLET

Bed, Scanning, Nuclear

SIEMENS GAMMASONICS, INC.

The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Cardiac Spect Pallet.

Pre-market Notification Details

Device IDK912286
510k NumberK912286
Device Name:CARDIAC SPECT PALLET
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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