The following data is part of a premarket notification filed by B C Medical Ltd. with the FDA for Arc-600.
| Device ID | K933100 |
| 510k Number | K933100 |
| Device Name: | ARC-600 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | B C MEDICAL LTD. 3755 RICHELIEU ST-HUBERT, QC CANADA J3y 7p9, CA |
| Contact | Yvan Giard |
| Correspondent | Yvan Giard B C MEDICAL LTD. 3755 RICHELIEU ST-HUBERT, QC CANADA J3y 7p9, CA |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-24 |
| Decision Date | 1993-11-08 |