FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
K Number: K113243
·
Decision Mar 28, 2012
Classifications
1
FEI Numbers
67
Registration Numbers
68
Same Product Code
72
Applicant Total
24
Review Days
147
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Basic Information
- Device Name
- EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
- K Number
- K113243
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Eps Bio Technology Corp.
- Date Received
- November 2, 2011
- Decision Date
- March 28, 2012
- Product Code
- LFR
- 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 |
|---|---|---|---|
| LFR | Glucose Dehydrogenase, Glucose | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K182057 | EasyMax BT Self-Monitoring Blood Glucose System | Aug 24, 2018 | Substantially Equivalent |
| K133537 | EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM | Apr 28, 2014 | Substantially Equivalent |
| K133389 | EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM | Apr 15, 2014 | Substantially Equivalent |
| K133647 | EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM | Feb 27, 2014 | Substantially Equivalent |
| K121207 | EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | May 18, 2012 | Substantially Equivalent |
| K112901 | EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | Dec 23, 2011 | Substantially Equivalent |
| K111728 | EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | Sep 16, 2011 | Substantially Equivalent |
| K112272 | EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | Sep 7, 2011 | Substantially Equivalent |