PHYSIOGLOVE ES

Electrocardiograph

COMMWELL LTD.

The following data is part of a premarket notification filed by Commwell Ltd. with the FDA for Physioglove Es.

Pre-market Notification Details

Device IDK050674
510k NumberK050674
Device Name:PHYSIOGLOVE ES
ClassificationElectrocardiograph
Applicant COMMWELL LTD. 555 THIRTEENTH ST., NW Washington,  DC  20004 -1109
ContactJonathan S Kahn
CorrespondentJonathan S Kahn
COMMWELL LTD. 555 THIRTEENTH ST., NW Washington,  DC  20004 -1109
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-15
Decision Date2006-04-25
Summary:summary

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