The following data is part of a premarket notification filed by G.w.b. Intl., Ltd. with the FDA for Digital Ultrasound Imaging System Dub 20.
| Device ID | K896029 |
| 510k Number | K896029 |
| Device Name: | DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | G.W.B. INTL., LTD. P.O. BOX 801 Sudbury, MA 01776 |
| Contact | Georg Bohsack |
| Correspondent | Georg Bohsack G.W.B. INTL., LTD. P.O. BOX 801 Sudbury, MA 01776 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-17 |
| Decision Date | 1990-01-12 |