The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Modification To Escort Ii+ 400 Series 9escort Prism) Monitor, Models 20400, 20401, 20403, 20411, 20412, 20413, 20414.
| Device ID | K014294 |
| 510k Number | K014294 |
| Device Name: | MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 |
| Classification | Oximeter |
| Applicant | MEDICAL DATA ELECTRONICS 12723 WENTWORTH ST. Arleta, CA 91331 |
| Contact | Gregory Alkire |
| Correspondent | Gregory Alkire MEDICAL DATA ELECTRONICS 12723 WENTWORTH ST. Arleta, CA 91331 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-28 |
| Decision Date | 2002-01-25 |
| Summary: | summary |