The following data is part of a premarket notification filed by Tomtec Imaging Systems, Gmbh with the FDA for Echo Scan, Easy Scan.
| Device ID | K993394 |
| 510k Number | K993394 |
| Device Name: | ECHO SCAN, EASY SCAN |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 Unterschleissheim, DE D-85716 |
| Contact | Florian Eisenberger |
| Correspondent | Florian Eisenberger TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 Unterschleissheim, DE D-85716 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-08 |
| Decision Date | 1999-11-05 |
| Summary: | summary |