The following data is part of a premarket notification filed by A&d Company, Ltd. with the FDA for A & D Medical Ua-1000 Family Dagital Blood Pressure Monitors.
Device ID | K111686 |
510k Number | K111686 |
Device Name: | A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | A&D COMPANY, LTD. 1756 AUTOMATION PARKWAY San Jose, CA 9513 |
Contact | Jerry Wang |
Correspondent | Jerry Wang A&D COMPANY, LTD. 1756 AUTOMATION PARKWAY San Jose, CA 9513 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-16 |
Decision Date | 2011-08-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00093764602931 | K111686 | 000 |
00093764602870 | K111686 | 000 |