K801950 is an FDA 510(k) clearance for the BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO. This device is classified as a Changer, Radiographic Film/cassette (Class II - Special Controls, product code KPX).
Submitted by B C Medical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980, 49 days after receiving the submission on August 15, 1980.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1860.
| 510(k) Number | K801950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 1980 |
| Decision Date | October 03, 1980 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | KPX — Changer, Radiographic Film/cassette |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1860 |