Sein Electronics Co., Ltd. is one of 13065 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Sein Electronics Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100, FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311, DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400
12
Total
12
Cleared
0
Denied
Sein Electronics Co., Ltd. has 12 FDA 510(k) cleared cardiovascular devices. Based in Mahwah, US.
Historical record: 12 cleared submissions from 1991 to 2005.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Sein Electronics Co., Ltd.
12 devices
Cleared
Dec 07, 2005
SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
Chemistry
126d
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
Feb 11, 2000
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
Neurology
296d
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