PMA P110014S005

Device
MARGINPROBE SYSTEM
Applicant
Dilon Medical Technologies, Ltd.
PMA number
P110014
Supplement
S005
Product code
OEE
Decision date
2015-05-18
Classification
Diagnostic Low Electric Field
Generic name
Diagnostic low electric field
Approval order statement
TWO CHANGES TO THE CALIBRATION PROBE CONTROL (CPC) AND SENSOR SUB-ASSEMBLIES IN THE MARGINPROBE SYSTEM

Current openFDA PMA Record#

Device
MARGINPROBE SYSTEM
Applicant
Dilon Medical Technologies, Ltd.
PMA number
P110014
Supplement
S005
Product code
OEE
Generic name
Diagnostic low electric field
Decision date
2015-05-18
Decision code
OK30
Date received
2015-04-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
TWO CHANGES TO THE CALIBRATION PROBE CONTROL (CPC) AND SENSOR SUB-ASSEMBLIES IN THE MARGINPROBE SYSTEM