Medical Device Manufacturer · US , Los Angeles , CA

Citizen Watch Co., Ltd. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1991

Recent clearances: BLOOD PRESSURE METER, MODEL CH-432, BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471, CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B)

8
Total
8
Cleared
0
Denied

Citizen Watch Co., Ltd. is a Japanese watchmaker established in 1918, with a manufacturing facility in Los Angeles, US. The company is known for innovative timepiece technologies including Eco-Drive light-powered movements and advanced materials like Super Titanium.

Citizen has received 8 FDA 510(k) clearances from 8 total submissions, with no denied submissions on record. The company's FDA regulatory activity focused exclusively on Cardiovascular devices, specifically blood pressure monitors and sphygmomanometers. Clearances span from 1991 to 2006, representing a historical record of device submissions.

The company's cleared Cardiovascular portfolio included digital blood pressure meters, wrist and finger sphygmomanometers, and electronic pulse monitors across multiple model variants. This regulatory history reflects Citizen's historical involvement in consumer health monitoring devices.

Explore the complete list of device names, model numbers, and clearance dates in the database records below.

510(k) submissions have been managed by Tuv Rheinland of North America, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - Citizen Watch Co., Ltd.

8 devices
1-8 of 8
Filters
All8 Cardiovascular 8