Submission Details
| 510(k) Number | K915202 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 1991 |
| Decision Date | May 15, 1992 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
K915202 is an FDA 510(k) clearance for the INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPH..
Submitted by Siemens Burdick, Inc. (Miltoon, US). The FDA issued a Cleared decision on May 15, 1992, 179 days after receiving the submission on November 18, 1991.
This device falls under the Cardiovascular FDA review panel.
| 510(k) Number | K915202 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 1991 |
| Decision Date | May 15, 1992 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LOS |
| Device Class | — |