neoBLUE Radiometer - Blue light radiometer: An instrument designed to measure the radiant flux (radiant power) in the spectral range of 400 to 500 nm(i.e., blue) during bilirubinemia treatment for newborns and infants
2023-05-30
Derungs Licht AG
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1000312377 | 1000312377 | Derungs Licht AG | 1 | N | 2026-01-01 | Hofmattrasse 12 Gossau Sankt Gallen CH 9200 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 81026 | 1809885698 | K053364 | HALUX IRIS EXAMINATION AND SURGICAL LAMP | FTD | 2006-02-23 |
| 81026 | 1306203066 | ||||
| 81026 | 1367024050 | ||||
| 81026 | 1459135781 | ||||
| 81026 | 2051239051 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FTD | 1 | 2006-02-23 |
GUDID#
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