K800932 is an FDA 510(k) clearance for the ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120. This device is classified as a Cable, Transducer And Electrode, Patient, (including Connector) (Class II - Special Controls, product code DSA).
Submitted by R2 Corp. (Mchenry, 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 870.2900.
| 510(k) Number | K800932 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 | DSA — Cable, Transducer And Electrode, Patient, (including Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2900 |