FDA Device Establishments · JSON-LD · Markdown
FEI 3023460764 · Repack or Relabel Medical Device Manufacture Medical Device · Status: Active
| FEI Number | 3023460764 |
|---|---|
| Owner / Operator | Auris Health, Inc. (#10057462) |
| Address | 170 Baytech Drive, San Jose, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | EOQ, JAK |
| Regulation § (21 CFR) | 874.4680, 892.1750 |
| Proprietary names | Monarch Navigation Field Generator Mount (MON-000006 - 210-000343-00); Monarch Bronchoscope (MBR-000211-A); Monarch Navigation Field Generator (MON-000006 - 210-000344-00); Monarch Tower (MON-000006 - 210-001896-00); Monarch Cart (MON-000006 - 210-001887-00); Monarch Navigation Patient Sensors (MON-000705); Monarch Controller (MON-000706); Bronchoscope Sheath Valve (MBR-000020); Bronchoscope Patient Introducer Mount (MON-000006 - 210-000346-00); Monarch Pre-op Planning System Kit (MON-000707) |
Source: openFDA. Public-domain (CC0).