K871435 is an FDA 510(k) clearance for the BARD EMS SYSTEM 6000 E.S.U.. This device is classified as a Apparatus, Electrosurgical (Class II - Special Controls, product code HAM).
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on May 11, 1987, 28 days after receiving the submission on April 13, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K871435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 1987 |
| Decision Date | May 11, 1987 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HAM — Apparatus, Electrosurgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |