K800935 is an FDA 510(k) clearance for the R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS). This device is classified as a Electrode, Electrocardiograph (Class II - Special Controls, product code DRX).
Submitted by R2 Corp. (Walker, US). The FDA issued a Cleared decision on May 23, 1980, 32 days after receiving the submission on April 21, 1980.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2360.
| 510(k) Number | K800935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 1980 |
| Decision Date | May 23, 1980 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRX — Electrode, Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2360 |