K946378 is an FDA 510(k) clearance for the BCM 400CP. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by B C Medical , Ltd. (J3y 7p9, CA). The FDA issued a Cleared decision on May 4, 1995, 132 days after receiving the submission on December 23, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K946378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1994 |
| Decision Date | May 04, 1995 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |