CARDIAC CAMERA

Camera, Scintillation (gamma)

SIEMENS GAMMASONICS, INC.

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

Pre-market Notification Details

Device IDK833811
510k NumberK833811
Device Name:CARDIAC CAMERA
ClassificationCamera, Scintillation (gamma)
Applicant SIEMENS GAMMASONICS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeIYX  
CFR Regulation Number892.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-14
Decision Date1983-12-27

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