The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Draeger Jaundice Meter Jm-105.
| Device ID | K133175 |
| 510k Number | K133175 |
| Device Name: | DRAEGER JAUNDICE METER JM-105 |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | DRAEGER MEDICAL SYSTEMS, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | Bryan Overton |
| Correspondent | Bryan Overton DRAEGER MEDICAL SYSTEMS, IND. 3135 QUARRY RD. Telford, PA 18969 |
| Product Code | MQM |
| CFR Regulation Number | 862.1113 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-11-13 |
| Summary: | summary |