Submission Details
| 510(k) Number | K961014 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 13, 1996 |
| Decision Date | July 31, 1996 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
K961014 is an FDA 510(k) clearance for the QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH, submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on July 31, 1996, 140 days after receiving the submission on March 13, 1996. This device falls under the Cardiovascular review panel.
| 510(k) Number | K961014 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 13, 1996 |
| Decision Date | July 31, 1996 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LOS |
| Device Class | — |