The following data is part of a premarket notification filed by A&d Company, Ltd with the FDA for A&d Medical Blood Pressure Monitors.
Device ID | K173065 |
510k Number | K173065 |
Device Name: | A&D Medical Blood Pressure Monitors |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | A&D Company, Ltd 1756 Automation Parkway San Jose, CA 95131 |
Contact | Jerry Wang |
Correspondent | Jerry Wang A&D Company, Ltd 1756 Automation Parkway San Jose, CA 95131 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-29 |
Decision Date | 2019-04-24 |