K790144 is an FDA 510(k) clearance for the TELEMETRY SYSTEM 315. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Ge Medical Systems Information Technologies (Mchenry, US). The FDA issued a Cleared decision on February 23, 1979, 35 days after receiving the submission on January 19, 1979.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K790144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1979 |
| Decision Date | February 23, 1979 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2910 |