Sein Electronics Co., Ltd.
Anyang-City, Kyungki-Do, KR
Sein Electronics Co., Ltd. appears in FDA device records in Anyang-City, Kyungki-Do, KR. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Sein Electronics Co., Ltd. between 1991 and 2005. The busiest year on record is 2000, with 3. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1996 | 2 |
| 1999 | 1 |
| 2000 | 3 |
| 2001 | 1 |
| 2004 | 3 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K052108 | SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 | NBW | Substantially Equivalent | |
| K042138 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 | DXN | Substantially Equivalent | |
| K042014 | DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 | DXN | Substantially Equivalent | |
| K032927 | FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K012054 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 | DXN | Substantially Equivalent | |
| K003711 | AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P | DXN | Substantially Equivalent | |
| K003282 | FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H | DXN | Substantially Equivalent | |
| K991397 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS | GZJ | Substantially Equivalent | |
| K973078 | WRIST BLOOD PRESSURE METER MODEL SE-330 | DPW | Substantially Equivalent | |
| K952827 | FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 | DXN | Substantially Equivalent | |
| K952826 | FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000 | DXN | Substantially Equivalent | |
| K912588 | AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS | DXN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain