FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K Number: K121207
·
Decision May 18, 2012
Classifications
1
FEI Numbers
66
Registration Numbers
67
Same Product Code
72
Applicant Total
21
Review Days
28
Basic Information
- Device Name
- EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
- K Number
- K121207
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- EPS BIO TECHNOLOGY CORP.
- Date Received
- April 20, 2012
- Decision Date
- May 18, 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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Other Clearances by EPS BIO TECHNOLOGY CORP.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K113243 | EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM | Mar 28, 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 |
| K102345 | EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 | Jun 21, 2011 | Substantially Equivalent |
| K101037 | EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 | May 23, 2011 | Substantially Equivalent |
| K101457 | EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 | Jul 1, 2010 | Substantially Equivalent |