CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER— 510(k) K954547
Substantially EquivalentCitizen Watch Co., Ltd.
FDA 510(k) clearance K954547 for CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER, Substantially Equivalent on 1997-04-01. Applicant: Citizen Watch Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Citizen Watch 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
- Washington, DC, 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 Citizen Watch Co., Ltd.
view all- K061161 — BLOOD PRESSURE METER, MODEL CH-311B
- K052046 — BLOOD PRESSURE METER, MODEL CH-432
- K001244 — BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
- K984223 — BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471
- K973061 — CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B)
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.