FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
K Number: K052108
·
Decision Dec 7, 2005
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
12
Review Days
126
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Basic Information
- Device Name
- SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
- K Number
- K052108
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sein Electronics Co., Ltd.
- Date Received
- August 3, 2005
- Decision Date
- December 7, 2005
- Product Code
- NBW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | FDA class 2 | Clinical Chemistry |
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Other Clearances by Sein Electronics Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K003282 | FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H | Nov 1, 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 |