K914839 is an FDA 510(k) clearance for the COMPEL E. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 2, 1992, 160 days after receiving the submission on October 25, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K914839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1991 |
| Decision Date | April 02, 1992 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |