The following data is part of a premarket notification filed by Analogic Corporation with the FDA for Fetalgard Lite-nibp, Model Fgl-nibp.
| Device ID | K051903 |
| 510k Number | K051903 |
| Device Name: | FETALGARD LITE-NIBP, MODEL FGL-NIBP |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ANALOGIC CORPORATION 8 CENTENNIAL DR. Peabody, MA 01960 |
| Contact | Janet Kwiatkowski |
| Correspondent | Janet Kwiatkowski ANALOGIC CORPORATION 8 CENTENNIAL DR. Peabody, MA 01960 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-13 |
| Decision Date | 2005-12-27 |
| Summary: | summary |