K890711 is an FDA 510(k) clearance for the DUAL GRAPH (TM) RECORDER-MONITOR. This device is classified as a Recorder, Paper Chart (Class I - General Controls, product code DSF).
Submitted by Somatics, Inc. (Lake Bluff, US). The FDA issued a Cleared decision on June 2, 1989, 109 days after receiving the submission on February 13, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2810.
| 510(k) Number | K890711 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1989 |
| Decision Date | June 02, 1989 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSF — Recorder, Paper Chart |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.2810 |