The following data is part of a premarket notification filed by Electromed Imaging Inc. with the FDA for Cardio Vascular Information Enhanced Workstation.
| Device ID | K031638 |
| 510k Number | K031638 |
| Device Name: | CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | ELECTROMED IMAGING INC. 440 ARMAND-FRAPPIER BLVD.,#250 Laval, Quebec, CA H7v 4b4 |
| Contact | Warren Baker |
| Correspondent | Warren Baker ELECTROMED IMAGING INC. 440 ARMAND-FRAPPIER BLVD.,#250 Laval, Quebec, CA H7v 4b4 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-27 |
| Decision Date | 2003-07-21 |
| Summary: | summary |