Luma Wrap
Blanket, Neonatal Phototherapy
Salter Labs
The following data is part of a premarket notification filed by Salter Labs with the FDA for Luma Wrap.
Pre-market Notification Details
| Device ID | K142416 |
| 510k Number | K142416 |
| Device Name: | Luma Wrap |
| Classification | Blanket, Neonatal Phototherapy |
| Applicant | Salter Labs 2365 Camino Vida Roble Carlsbad, CA 92011 |
| Contact | Aurelia Browndridge |
| Correspondent | Aurelia Brownridge Salter Labs 2365 Camino Vida Roble Carlsbad, CA 92011 |
| Product Code | PDH |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-28 |
| Decision Date | 2015-06-12 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607411930393 | K142416 | 000 |
| 00607411930386 | K142416 | 000 |
| 00607411930379 | K142416 | 000 |
Trademark Results [Luma Wrap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUMA WRAP 86058270 4619743 Live/Registered |
BEEVERS MANUFACTURING & SUPPLY, INC. 2013-09-06 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.