K961138 is an FDA 510(k) clearance for the ESORT II + 400 SERIES MONITOR. This device is classified as a Pacemaker, Cardiac, External Transcutaneous (non-invasive) (Class II - Special Controls, product code DRO).
Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on December 10, 1996, 264 days after receiving the submission on March 21, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5550.
| 510(k) Number | K961138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1996 |
| Decision Date | December 10, 1996 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DRO — Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5550 |