Submission Details
| 510(k) Number | K854162 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 15, 1985 |
| Decision Date | December 09, 1985 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K854162 is an FDA 510(k) clearance for the SUPPORT ARM, submitted by Healthmate, Inc. (Northbrook, US). The FDA issued a Cleared decision on December 9, 1985, 55 days after receiving the submission on October 15, 1985. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K854162 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 15, 1985 |
| Decision Date | December 09, 1985 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |