FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K Number: K050760
·
Decision Sep 13, 2005
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
83
Applicant Total
264
Review Days
173
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Basic Information
- Device Name
- ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
- K Number
- K050760
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- March 24, 2005
- Decision Date
- September 13, 2005
- Product Code
- LZG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LZG | Pump, Infusion, Insulin | FDA class 2 | General Hospital |
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Other Clearances by Roche Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K101196 | ACCU-CHEK ULTRFLEX INFUSION SET | Aug 27, 2010 | Substantially Equivalent |
| K093664 | AMPHETAMINES II ASSAY | Jul 28, 2010 | Substantially Equivalent |
| K101075 | ELECSYS INSULIN CALCHECK 5 | Jun 11, 2010 | Substantially Equivalent |
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| K092940 | COAGUCHEK XS PLUS PST SYSTEM | Mar 5, 2010 | Substantially Equivalent |
| K093700 | ELECSYS HCG STAT CALCHECK 5 | Mar 4, 2010 | Substantially Equivalent |