The following data is part of a premarket notification filed by Bv Medical Equipment Co. with the FDA for Cardiovue Cfs-100.
| Device ID | K900893 |
| 510k Number | K900893 |
| Device Name: | CARDIOVUE CFS-100 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | BV MEDICAL EQUIPMENT CO. 2605 CABOVER DR. SUITE 10 Hanover, MD 21076 |
| Contact | Jerry J Ditzel |
| Correspondent | Jerry J Ditzel BV MEDICAL EQUIPMENT CO. 2605 CABOVER DR. SUITE 10 Hanover, MD 21076 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-27 |
| Decision Date | 1990-04-19 |