FDA.reportPublic FDA data

PMA P150046S004

Device
Nevisense
Applicant
Scibase AB
PMA number
P150046
Supplement
S004
Product code
ONV
Decision date
2020-04-30
Generic name
Electrical Impedance Spectrometer
Approval order statement
Approval for software changes to remove the reference measurement step from the device operation, introducing an in-device qualification module and lesion feedback mechanism to detect potential user errors.

Current openFDA PMA Record#

Device
Nevisense
Applicant
Scibase AB
PMA number
P150046
Supplement
S004
Product code
ONV
Generic name
Electrical Impedance Spectrometer
Decision date
2020-04-30
Decision code
APPR
Date received
2019-05-31
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for software changes to remove the reference measurement step from the device operation, introducing an in-device qualification module and lesion feedback mechanism to detect potential user errors.