K870205 is an FDA 510(k) clearance for the ROTAX-II BI-PLANE CIRCULAR ARM..
Submitted by B C Medical , Ltd. (Canada, CA). The FDA issued a Cleared decision on March 6, 1987, 45 days after receiving the submission on January 20, 1987.
This device falls under the Radiology FDA review panel.
| 510(k) Number | K870205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 1987 |
| Decision Date | March 06, 1987 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | — |
| Device Class | — |