PMA P150046S003
- Device
- Nevisense
- Applicant
- Scibase AB
- PMA number
- P150046
- Supplement
- S003
- Product code
- ONV
- Decision date
- 2018-12-11
- Classification
- Electrical Impedance Spectrometer
- Generic name
- Electrical Impedance Spectrometer
- Approval order statement
- Relocation of component contract manufacturer, Kitron ab, which manufactures the following major components of the Nevisense Device: Control Unit, Probe Unit, and Test Impedance Tools.
Current openFDA PMA Record#
- Device
- Nevisense
- Applicant
- Scibase AB
- PMA number
- P150046
- Supplement
- S003
- Product code
- ONV
- Generic name
- Electrical Impedance Spectrometer
- Decision date
- 2018-12-11
- Decision code
- OK30
- Date received
- 2018-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of component contract manufacturer, Kitron ab, which manufactures the following major components of the Nevisense Device: Control Unit, Probe Unit, and Test Impedance Tools.