GEMINI GXL

System, Tomography, Computed, Emission

PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Gemini Gxl.

Pre-market Notification Details

Device IDK042935
510k NumberK042935
Device Name:GEMINI GXL
ClassificationSystem, Tomography, Computed, Emission
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland,  OH  44143
ContactRae Ann Farrow
CorrespondentMorten Simon Christensen
UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara,  CA  95050
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-10-25
Decision Date2004-11-09
Summary:summary

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