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.
| Device | Nevisense |
| Classification Name | Electrical Impedance Spectrometer |
| Generic Name | Electrical Impedance Spectrometer |
| Applicant | SCIBASE AB |
| Date Received | 2018-07-06 |
| Decision Date | 2019-01-14 |
| PMA | P150046 |
| Supplement | S002 |
| Product Code | ONV |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SCIBASE AB kammakargatan 22 stockholm SE-11-1140 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150046 | | Original Filing |
| S004 |
2019-05-31 |
Normal 180 Day Track |
| S003 |
2018-11-21 |
30-day Notice |
| S002 |
2018-07-06 |
Normal 180 Day Track |
| S001 |
2018-05-09 |
Real-time Process |
NIH GUDID Devices