The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Fetalgard 3000 Fetal Monitor.
| Device ID | K983395 |
| 510k Number | K983395 |
| Device Name: | FETALGARD 3000 FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Contact | Steven Clarke |
| Correspondent | Steven Clarke ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-25 |
| Decision Date | 1999-08-12 |
| Summary: | summary |