The following data is part of a premarket notification filed by Tomtec Imaging Systems, Inc. with the FDA for Tomtec Echo-scan.
| Device ID | K963807 |
| 510k Number | K963807 |
| Device Name: | TOMTEC ECHO-SCAN |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TOMTEC IMAGING SYSTEMS, INC. 4775 WALNUT ST., SUITE C Boulder, CO 80301 |
| Contact | Kevin Morningstar |
| Correspondent | Kevin Morningstar TOMTEC IMAGING SYSTEMS, INC. 4775 WALNUT ST., SUITE C Boulder, CO 80301 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-23 |
| Decision Date | 1996-12-18 |
| Summary: | summary |