A&D Medical Blood Pressure Monitors— 510(k) K173065
Substantially EquivalentA&D Company, Ltd.
FDA 510(k) clearance K173065 for A&D Medical Blood Pressure Monitors, Substantially Equivalent on 2019-04-24. Applicant: A&D Company, Ltd.. Device class: 2.
Clearance details
- Applicant
- A&D Company, Ltd.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code DXN
view all- K260670 — YUWELL® Electronic Blood Pressure Monitor
- K260470 — Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
More clearances from A&D Company, Ltd.
view all- K212168 — A&D Medical UM-212BLE Blood Pressure Monitor
- K173191 — A&D Medical Blood Pressure Monitors
- K170196 — A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
- K163683 — A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor
- K151953 — A&D Medical TM-2657 Family of Digital Blood Pressure Monitors
Adverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.