The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort Ii+ 400 Series (escort Prism) Monitor.
| Device ID | K992411 |
| 510k Number | K992411 |
| Device Name: | ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Contact | David M Trueblood |
| Correspondent | David M Trueblood MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Product Code | DRT |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DTE |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-20 |
| Decision Date | 1999-08-18 |
| Summary: | summary |