The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Phototherapy Lamp 900iw501je Phototherapy Power Module 900iw502je.
| Device ID | K002414 |
| 510k Number | K002414 |
| Device Name: | PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Contact | Brett Whiston |
| Correspondent | Brett Whiston FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-07 |
| Decision Date | 2000-09-25 |