PMA P110014S004

Device
MARGINPROBE SYSTEM
Applicant
Dilon Medical Technologies, Ltd.
PMA number
P110014
Supplement
S004
Product code
OEE
Decision date
2014-10-22
Classification
Diagnostic Low Electric Field
Generic name
Diagnostic low electric field
Approval order statement
ADDITION OF A TEST JIG AND THE REPLACEMENT OF THE VACUUM PRESSURE REGULATOR COMPONENT.

Current openFDA PMA Record#

Device
MARGINPROBE SYSTEM
Applicant
Dilon Medical Technologies, Ltd.
PMA number
P110014
Supplement
S004
Product code
OEE
Generic name
Diagnostic low electric field
Decision date
2014-10-22
Decision code
OK30
Date received
2014-09-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A TEST JIG AND THE REPLACEMENT OF THE VACUUM PRESSURE REGULATOR COMPONENT.