BiliLux
Unit, Neonatal Phototherapy
Draeger Medical Systems, Inc.
The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Bililux.
Pre-market Notification Details
| Device ID | K172656 |
| 510k Number | K172656 |
| Device Name: | BiliLux |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | Draeger Medical Systems, Inc. 3135 Quarry Road Telford, PA 18969 |
| Contact | Gale Winarsky |
| Correspondent | Gale Winarsky Draeger Medical Systems, Inc. 3135 Quarry Road Telford, PA 18969 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-05 |
| Decision Date | 2018-05-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098094900 | K172656 | 000 |
Trademark Results [BiliLux]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BILILUX 87361700 5510903 Live/Registered |
Draegerwerk AG & Co. KGaA 2017-03-07 |
 BILILUX 79130939 4434546 Live/Registered |
CONG TY CO PHAN THUC PHAM BILILUX 2013-03-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.