FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H
K Number: K003282
·
Decision Nov 1, 2000
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
12
Review Days
13
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Basic Information
- Device Name
- FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H
- K Number
- K003282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sein Electronics Co., Ltd.
- Date Received
- October 19, 2000
- Decision Date
- November 1, 2000
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Sein Electronics Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K052108 | SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 | Dec 7, 2005 | Substantially Equivalent |
| K042138 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 | Aug 24, 2004 | Substantially Equivalent |
| K042014 | DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 | Aug 6, 2004 | Substantially Equivalent |
| K032927 | FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR | May 7, 2004 | Substantially Equivalent |
| K012054 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 | Aug 8, 2001 | Substantially Equivalent |
| K003711 | AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P | Dec 15, 2000 | Substantially Equivalent |
| K991397 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS | Feb 11, 2000 | Substantially Equivalent |
| K973078 | WRIST BLOOD PRESSURE METER MODEL SE-330 | May 20, 1999 | Substantially Equivalent |
| K952826 | FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000 | Nov 14, 1996 | Substantially Equivalent |
| K952827 | FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 | Nov 14, 1996 | Substantially Equivalent |