The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Nanoblutm 500.
| Device ID | K113206 |
| 510k Number | K113206 |
| Device Name: | NANOBLUTM 500 |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | Draeger Medical Systems, Inc. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | Bryan Overton |
| Correspondent | Bryan Overton Draeger Medical Systems, Inc. 3135 QUARRY RD. 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 | 2011-11-01 |
| Decision Date | 2012-02-17 |
| Summary: | summary |