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 | K182178 |
| 510k Number | K182178 |
| Device Name: | NeoBLUE Blanket LED Phototherapy System |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | Natus Medical Incorporated 5900 First Avenue South Seattle, WA 98108 |
| Contact | Judy Buckham |
| Correspondent | Judy Buckham 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 | 2018-08-13 |
| Decision Date | 2018-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830053686 | K182178 | 000 |
| 05713315011269 | K182178 | 000 |
| 05713315011276 | K182178 | 000 |
| 05713315011283 | K182178 | 000 |
| 05713315011313 | K182178 | 000 |
| 05713315011351 | K182178 | 000 |
| 05713315011405 | K182178 | 000 |
| 05713315011849 | K182178 | 000 |
| 05713315011856 | K182178 | 000 |
| 05713315011863 | K182178 | 000 |
| 00382830015394 | K182178 | 000 |
| 00382830015417 | K182178 | 000 |
| 00382830015424 | K182178 | 000 |
| 00382830015431 | K182178 | 000 |
| 05713315011252 | K182178 | 000 |