FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
K Number: K060343
·
Decision May 11, 2006
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
27
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
- K Number
- K060343
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3050
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sentech Korea Corp.
- Date Received
- February 10, 2006
- Decision Date
- May 11, 2006
- Product Code
- DJZ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DJZ | Devices, Breath Trapping, Alcohol | FDA class 1 | Clinical Toxicology |
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