The following data is part of a premarket notification filed by Tomtec Tomographic Technologies Gmbh with the FDA for Tomtec Echo-view.
| Device ID | K934139 |
| 510k Number | K934139 |
| Device Name: | TOMTEC ECHO-VIEW |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TOMTEC TOMOGRAPHIC TECHNOLOGIES GMBH 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook TOMTEC TOMOGRAPHIC TECHNOLOGIES GMBH 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-25 |
| Decision Date | 1995-01-25 |