The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort-link (model E3200).
Device ID | K901591 |
510k Number | K901591 |
Device Name: | ESCORT-LINK (MODEL E3200) |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
Contact | Chip Harlow |
Correspondent | Chip Harlow MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. 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 | 1990-04-05 |
Decision Date | 1990-05-15 |