Medical Device Manufacturer · US , Mahwah , NJ

Sein Electronics Co., Ltd. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1991

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sein Electronics Co., Ltd. Cardiovascular ✕

10 devices

1-10 of 10

Cleared Aug 24, 2004

FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311

Cardiovascular · 15d

Cleared Aug 06, 2004

DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400

Cardiovascular · 10d

Cleared May 07, 2004

FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR

Cardiovascular · 228d

Cleared Aug 08, 2001

FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312

Cardiovascular · 37d

Cleared Dec 15, 2000

AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P

Cardiovascular · 14d

Cleared Nov 01, 2000

FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H

Cardiovascular · 13d

Cleared May 20, 1999

WRIST BLOOD PRESSURE METER MODEL SE-330

Cardiovascular · 640d

Cleared Nov 14, 1996

FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000

Cardiovascular · 513d

Cleared Nov 14, 1996

FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000

Cardiovascular · 513d

Cleared Dec 19, 1991

AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS

Cardiovascular · 190d