FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
K Number: K123935
·
Decision Apr 12, 2013
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
9
Review Days
113
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Basic Information
- Device Name
- IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
- K Number
- K123935
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Andon Medical Co., Ltd.
- Date Received
- December 20, 2012
- Decision Date
- April 12, 2013
- 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 Andon Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K120813 | BLOOD GLUCOSE MONITORING SYSTEM | Dec 7, 2012 | Substantially Equivalent |
| K110017 | AG-608N BLOOD GLUCOSE MONITORING SYSTEM | Jan 18, 2012 | Substantially Equivalent |
| K112738 | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE | Sep 30, 2011 | Substantially Equivalent |
| K102678 | ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS | Aug 26, 2011 | Substantially Equivalent |
| K101307 | BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 | Aug 9, 2011 | Substantially Equivalent |
| K093755 | AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM | Jul 15, 2011 | Substantially Equivalent |
| K102609 | KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Dec 9, 2010 | Substantially Equivalent |
| K093262 | AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM | Jul 13, 2010 | Substantially Equivalent |