The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort Non-invasive Blood Pressure Option.
Device ID | K884742 |
510k Number | K884742 |
Device Name: | ESCORT NON-INVASIVE BLOOD PRESSURE OPTION |
Classification | System, Measurement, Blood-pressure, Non-invasive |
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 | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-14 |
Decision Date | 1989-02-02 |