UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES— 510(k) K092514
Substantially EquivalentHangzhou Hua'An Medical & Health Instruments Co.,
FDA 510(k) clearance K092514 for UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES, Substantially Equivalent on 2009-12-04. Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,. Device class: 2.
Clearance details
- Applicant
- Hangzhou Hua'An Medical & Health Instruments Co.,
- 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
- Wuchang, Hangzhou, Zhejiang, CN
Recent devices under product code DXN
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- 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 Hangzhou Hua'An Medical & Health Instruments Co.,
view all- K122912 — DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
- K092447 — DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
- K041693 — WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
- K041692 — INFRARED EAR THERMOMETER, ET-100 SERIES
- K041694 — DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER
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.