CALYPSO 4D LOCALIZATION SYSTEM

Accelerator, Linear, Medical

CALYPSO MEDICAL TECHNOLOGIES INC

The following data is part of a premarket notification filed by Calypso Medical Technologies Inc with the FDA for Calypso 4d Localization System.

Pre-market Notification Details

Device IDK080726
510k NumberK080726
Device Name:CALYPSO 4D LOCALIZATION SYSTEM
ClassificationAccelerator, Linear, Medical
Applicant CALYPSO MEDICAL TECHNOLOGIES INC 2101 FOURTH AVE SUITE 500 Seattle,  WA  98121
ContactEric Meier
CorrespondentEric Meier
CALYPSO MEDICAL TECHNOLOGIES INC 2101 FOURTH AVE SUITE 500 Seattle,  WA  98121
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-14
Decision Date2008-05-14
Summary:summary

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