The following data is part of a premarket notification filed by International Hospital Supply Co. with the FDA for Phoenix Phototherapy Unit Cfl, Model 101.
| Device ID | K040853 |
| 510k Number | K040853 |
| Device Name: | PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101 |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | INTERNATIONAL HOSPITAL SUPPLY CO. AMSTEL 320-1 Amsterdam, NL 1017ap |
| Contact | Angelika Scherp |
| Correspondent | Angelika Scherp INTERNATIONAL HOSPITAL SUPPLY CO. AMSTEL 320-1 Amsterdam, NL 1017ap |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-01 |
| Decision Date | 2004-06-21 |
| Summary: | summary |