Submission Details
| 510(k) Number | K864072 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 20, 1986 |
| Decision Date | November 07, 1986 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
K864072 is an FDA 510(k) clearance for the ADEC 1005-C CHAIR, a Table, Examination, Medical, Powered (Class I — General Controls, product code LGX), submitted by Cherne Industries, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 7, 1986, 18 days after receiving the submission on October 20, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K864072 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 20, 1986 |
| Decision Date | November 07, 1986 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LGX — Table, Examination, Medical, Powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4960 |