The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort Ii+ 400 Series (escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411, 20412, 20413.
| Device ID | K000660 |
| 510k Number | K000660 |
| Device Name: | ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Contact | Cedric Navarro |
| Correspondent | Cedric Navarro MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-28 |
| Decision Date | 2000-03-28 |