Automatic Upper Arm Blood Pressure Monitor— 510(k) K193624
Substantially EquivalentDongguan E-Test Technology Co., Ltd.
FDA 510(k) clearance K193624 for Automatic Upper Arm Blood Pressure Monitor, Substantially Equivalent on 2020-07-10. Applicant: Dongguan E-Test Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Dongguan E-Test Technology Co., 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
- Dongguan, CN
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 Dongguan E-Test Technology Co., Ltd.
view all- K250231 — Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)
- K193621 — Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)
- K193627 — Automatic Upper Arm Blood Pressure Monitor
- K193628 — AGE Automatic Wrist Blood Pressure Monitor
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.