FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
EasyMax BT Self-Monitoring Blood Glucose System
K Number: K182057
·
Decision Aug 24, 2018
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
24
Review Days
24
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Basic Information
- Device Name
- EasyMax BT Self-Monitoring Blood Glucose System
- K Number
- K182057
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eps Bio Technology Corp.
- Date Received
- July 31, 2018
- Decision Date
- August 24, 2018
- 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 Eps Bio Technology Corp.
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| K121207 | EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | May 18, 2012 | 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 |