The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Esort Ii + 400 Series Monitor.
| Device ID | K961138 |
| 510k Number | K961138 |
| Device Name: | ESORT II + 400 SERIES MONITOR |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Contact | David M Trublood |
| Correspondent | David M Trublood MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-21 |
| Decision Date | 1996-12-10 |