The following data is part of a premarket notification filed by Natus Medical, Inc. with the FDA for Neoblue Cozy Led Phototherapy System.
| Device ID | K051869 |
| 510k Number | K051869 |
| Device Name: | NEOBLUE COZY LED PHOTOTHERAPY SYSTEM |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Luanne Ng |
| Correspondent | Luanne Ng NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-11 |
| Decision Date | 2005-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830053198 | K051869 | 000 |
| 00382830005678 | K051869 | 000 |