K000660 is an FDA 510(k) clearance for the ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413. 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 March 28, 2000, 29 days after receiving the submission on February 28, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5550.
| 510(k) Number | K000660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2000 |
| Decision Date | March 28, 2000 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRO — Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5550 |