The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Mde Escort 1000 & Mde Escor 2000.
Device ID | K842716 |
510k Number | K842716 |
Device Name: | MDE ESCORT 1000 & MDE ESCOR 2000 |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | MEDICAL DATA ELECTRONICS 12970 BRANFORD STREET UNIT 0 Arleta , CA 91331 - |
Contact | Chip Harlow |
Correspondent | Chip Harlow MEDICAL DATA ELECTRONICS 12970 BRANFORD STREET UNIT 0 Arleta , CA 91331 - |
Product Code | DXH |
CFR Regulation Number | 870.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-13 |
Decision Date | 1985-02-08 |