The following data is part of a premarket notification filed by B C Medical Ltd. with the FDA for Bcm-arc 105 X-ray Mobile Unit.
| Device ID | K890306 |
| 510k Number | K890306 |
| Device Name: | BCM-ARC 105 X-RAY MOBILE UNIT |
| Classification | System, X-ray, Mobile |
| Applicant | B C MEDICAL LTD. 3755 RICHELIEU ST-HUBERT, QC CANADA J3y 7p9, CA |
| Contact | Charles L Bechet |
| Correspondent | Charles L Bechet B C MEDICAL LTD. 3755 RICHELIEU ST-HUBERT, QC CANADA J3y 7p9, CA |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-04-17 |