FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
K Number: K093819
·
Decision Jun 9, 2010
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
9
Review Days
177
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Basic Information
- Device Name
- ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
- K Number
- K093819
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arkray Factory USA, Inc.
- Date Received
- December 14, 2009
- Decision Date
- June 9, 2010
- 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 Arkray Factory USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110709 | ARK CARE DIABETES MANAGMENT SYSTEM | May 19, 2011 | Substantially Equivalent |
| K092104 | ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM | Nov 24, 2009 | Substantially Equivalent |
| K091102 | ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS | Oct 23, 2009 | Substantially Equivalent |
| K090653 | POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM | Oct 9, 2009 | Substantially Equivalent |
| K090332 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 | Aug 14, 2009 | Substantially Equivalent |
| K082417 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 | Oct 21, 2008 | Substantially Equivalent |
| K073416 | ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM | Jun 13, 2008 | Substantially Equivalent |
| K063771 | GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM | Aug 9, 2007 | Substantially Equivalent |