Submission Details
| 510(k) Number | K914969 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 05, 1991 |
| Decision Date | March 26, 1992 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
K914969 is an FDA 510(k) clearance for the E350I ELECTROCARDIOGRAPH..
Submitted by Siemens Burdick, Inc. (Miltoon, US). The FDA issued a Cleared decision on March 26, 1992, 142 days after receiving the submission on November 5, 1991.
This device falls under the Cardiovascular FDA review panel.
| 510(k) Number | K914969 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 05, 1991 |
| Decision Date | March 26, 1992 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LOS |
| Device Class | — |