The following data is part of a premarket notification filed by Draeger Medical Infant Care, Inc. with the FDA for Jaundice Meter, Model Jm 103.
| Device ID | K042522 |
| 510k Number | K042522 |
| Device Name: | JAUNDICE METER, MODEL JM 103 |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | DRAEGER MEDICAL INFANT CARE, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Contact | Thomas M Mcintosh |
| Correspondent | Thomas M Mcintosh DRAEGER MEDICAL INFANT CARE, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Product Code | MQM |
| CFR Regulation Number | 862.1113 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-16 |
| Decision Date | 2005-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098000246 | K042522 | 000 |
| 04049098000161 | K042522 | 000 |