The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Phototherapy Lamp.
| Device ID | K984589 |
| 510k Number | K984589 |
| Device Name: | PHOTOTHERAPY LAMP |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | MEDELA, INC. 4610 PRIME PKWY. P.O. BOX 660 Mchenry, IL 60050 -7005 |
| Contact | Stephen D Smith |
| Correspondent | Stephen D Smith MEDELA, INC. 4610 PRIME PKWY. P.O. BOX 660 Mchenry, IL 60050 -7005 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-24 |
| Decision Date | 1999-04-20 |