The following data is part of a premarket notification filed by Ep Medsystems with the FDA for Viewmate Ultrasound Imaging System.
| Device ID | K031066 |
| 510k Number | K031066 |
| Device Name: | VIEWMATE ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 ROUTE 73 N. BLDG. D West Berlin, NJ 08091 |
| Contact | John J Talarico |
| Correspondent | John J Talarico EP MEDSYSTEMS COOPER RUN EXECUTIVE PARK 575 ROUTE 73 N. BLDG. D West Berlin, NJ 08091 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-03 |
| Decision Date | 2003-10-17 |