The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Medlink Diagnostic Offline Workstation.
| Device ID | K002144 |
| 510k Number | K002144 |
| Device Name: | MEDLINK DIAGNOSTIC OFFLINE WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Terrence J Sweeney |
| Correspondent | Terrence J Sweeney ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-17 |
| Decision Date | 2000-09-28 |