PMA P150046S002

Device: Nevisense
Applicant: Scibase AB
PMA number: P150046
Supplement: S002
Product code: ONV
Decision date: 2019-01-14
Classification: Electrical Impedance Spectrometer
Generic name: Electrical Impedance Spectrometer
Approval order statement: Approval for hardware and software modifications including replacement of discontinued PC board and associated HW and SW changes; addition of radio module; LVDS ferrite bead replacement; new cells for rechargeable battery and reprogrammed battery safety circuit; replacement of speaker; software updates to adapt to new platform; NeviFile software; Quick Measurement function; reference measurement feedback dialogs.

Current openFDA PMA Record#

Device: Nevisense
Applicant: Scibase AB
PMA number: P150046
Supplement: S002
Product code: ONV
Generic name: Electrical Impedance Spectrometer
Decision date: 2019-01-14
Decision code: APPR
Date received: 2018-07-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for hardware and software modifications including replacement of discontinued PC board and associated HW and SW changes; addition of radio module; LVDS ferrite bead replacement; new cells for rechargeable battery and reprogrammed battery safety circuit; replacement of speaker; software updates to adapt to new platform; NeviFile software; Quick Measurement function; reference measurement feedback dialogs.