ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR— 510(k) K911965
Substantially EquivalentCitizen Watch Co., Ltd.
FDA 510(k) clearance K911965 for ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR, Substantially Equivalent on 1991-10-28. Applicant: Citizen Watch Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Citizen Watch Co., Ltd.
- Product code
- 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
- Los Angeles, CA, US
Recent devices under product code DXN
view all- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
- K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
- K253425 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)
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.