The following data is part of a premarket notification filed by B C Medical Ltd. with the FDA for Bcm-302 Collimating Cone & Compensatin.
| Device ID | K801949 |
| 510k Number | K801949 |
| Device Name: | BCM-302 COLLIMATING CONE & COMPENSATIN |
| Classification | Nephelometer |
| Applicant | B C MEDICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JZW |
| CFR Regulation Number | 866.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-15 |
| Decision Date | 1980-10-03 |