The following data is part of a premarket notification filed by Tomtec Imaging Systems, Gmbh with the FDA for Echocom, Imagecom, Dokucom.
| Device ID | K001592 |
| 510k Number | K001592 |
| Device Name: | ECHOCOM, IMAGECOM, DOKUCOM |
| Classification | Computer, Diagnostic, Programmable |
| 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 | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-23 |
| Decision Date | 2000-06-16 |