FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
K Number: K120649
·
Decision Jul 6, 2012
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
35
Review Days
126
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Basic Information
- Device Name
- AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K Number
- K120649
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apex BioTechnology Corp.
- Date Received
- March 2, 2012
- Decision Date
- July 6, 2012
- 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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