K800934 is an FDA 510(k) clearance for the R2 ESU CABLE-ADAPTER MODELS 160,161. This device is classified as a Cable, Electrode (Class II - Special Controls, product code IKD).
Submitted by R2 Corp. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1980, 29 days after receiving the submission on April 21, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1175.
| 510(k) Number | K800934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 1980 |
| Decision Date | May 20, 1980 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IKD — Cable, Electrode |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1175 |