The following data is part of a premarket notification filed by B C Medical Ltd. with the FDA for Bcm 400cp.
| Device ID | K946378 |
| 510k Number | K946378 |
| Device Name: | BCM 400CP |
| Classification | System, X-ray, Angiographic |
| Applicant | B C MEDICAL LTD. 3755 RICHELIEU ST-HUBERT, QC CANADA J3y 7p9, CA |
| Contact | Charles Bechet |
| Correspondent | Charles Bechet B C MEDICAL LTD. 3755 RICHELIEU ST-HUBERT, QC CANADA J3y 7p9, CA |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-23 |
| Decision Date | 1995-05-04 |