The following data is part of a premarket notification filed by Tomographic Tech with the FDA for Echo-scan.
| Device ID | K941322 |
| 510k Number | K941322 |
| Device Name: | ECHO-SCAN |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TOMOGRAPHIC TECH 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook TOMOGRAPHIC TECH 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 | 1994-03-18 |
| Decision Date | 1995-07-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ECHO-SCAN 74584572 not registered Dead/Abandoned |
TomTec Imaging Systems, Inc. 1994-10-12 |
![]() ECHO-SCAN 72217555 0801970 Live/Registered |
METRIX, INCORPORATED 1965-04-28 |