The following data is part of a premarket notification filed by Natus Medical Incorporated with the FDA for Neoblue Blanket Led Phototherapy System.
| Device ID | K103589 |
| 510k Number | K103589 |
| Device Name: | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | NATUS MEDICAL INCORPORATED 5900 FIRST AVENUE SOUTH Seattle, WA 98108 |
| Contact | Julie Freed |
| Correspondent | Julie Freed NATUS MEDICAL INCORPORATED 5900 FIRST AVENUE SOUTH Seattle, WA 98108 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-07 |
| Decision Date | 2011-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830015523 | K103589 | 000 |
| 00382830015516 | K103589 | 000 |