The following data is part of a premarket notification filed by Infimed, Inc. with the FDA for Cardiovascular Workstation, Model Cws 5000/cws 3000.
| Device ID | K992575 |
| 510k Number | K992575 |
| Device Name: | CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000 |
| Classification | System, Image Processing, Radiological |
| Applicant | INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Contact | Ralph J Flatau |
| Correspondent | Ralph J Flatau INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-02 |
| Decision Date | 1999-10-07 |
| Summary: | summary |