PMA P110014S006

Device: MARGINPROBE SYSTEM
Applicant: Dilon Medical Technologies, Ltd.
PMA number: P110014
Supplement: S006
Product code: OEE
Decision date: 2016-03-14
Classification: Diagnostic Low Electric Field
Generic name: Diagnostic low electric field
Approval order statement: Approval for changes to the console in order to make the console compliant with the European Commission Restriction of the use of certain hazardous substances (RoHS) directive requirements.

Current openFDA PMA Record#

Device: MARGINPROBE SYSTEM
Applicant: Dilon Medical Technologies, Ltd.
PMA number: P110014
Supplement: S006
Product code: OEE
Generic name: Diagnostic low electric field
Decision date: 2016-03-14
Decision code: APPR
Date received: 2015-07-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes to the console in order to make the console compliant with the European Commission Restriction of the use of certain hazardous substances (RoHS) directive requirements.