The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Bilichek Non-invasive Bilirubin Analyzer.
| Device ID | K983071 |
| 510k Number | K983071 |
| Device Name: | BILICHEK NON-INVASIVE BILIRUBIN ANALYZER |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | RESPIRONICS, INC. 1501 ARDMORE BLVD. Pittsburgh, PA 15221 -4401 |
| Contact | Timothy Y Cowart |
| Correspondent | Timothy Y Cowart RESPIRONICS, INC. 1501 ARDMORE BLVD. Pittsburgh, PA 15221 -4401 |
| Product Code | MQM |
| CFR Regulation Number | 862.1113 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-02 |
| Decision Date | 1999-03-04 |