The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort-link Central Station Monitor Model 20500.
Device ID | K982104 |
510k Number | K982104 |
Device Name: | ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 |
Classification | Monitor, St Segment With 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 | MLD |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-15 |
Decision Date | 1998-11-25 |
Summary: | summary |