Submission Details
| 510(k) Number | K882010 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 13, 1988 |
| Decision Date | July 13, 1988 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
K882010 is an FDA 510(k) clearance for the POWER EXAMINATION TABLE, a Table, Examination, Medical, Powered (Class I — General Controls, product code LGX), submitted by Enochs Mfg., Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 13, 1988, 61 days after receiving the submission on May 13, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K882010 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 13, 1988 |
| Decision Date | July 13, 1988 |
| Days to Decision | 61 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 |