The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Nomos Bat Ultrasound Localization And Positioning System.
| Device ID | K981424 |
| 510k Number | K981424 |
| Device Name: | NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
| Contact | Marvin L Sussman |
| Correspondent | Marvin L Sussman NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-20 |
| Decision Date | 1998-07-17 |
| Summary: | summary |