The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Ob-1 Fetal Monitor.
| Device ID | K011304 |
| 510k Number | K011304 |
| Device Name: | OB-1 FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | ANALOGIC CORP. 360 AUDUBON RD. Wakefield, MA 01880 |
| Contact | Steven A Clarke |
| Correspondent | Steven A Clarke ANALOGIC CORP. 360 AUDUBON RD. Wakefield, MA 01880 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-30 |
| Decision Date | 2001-05-29 |