FDA 510(k)
FDA class 1
Substantially Equivalent
🇰🇷 South Korea
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
K Number: K061922
·
Decision Oct 30, 2006
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
27
Applicant Total
3
Review Days
115
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Basic Information
- Device Name
- BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
- K Number
- K061922
- 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
- July 7, 2006
- Decision Date
- October 30, 2006
- Product Code
- DJZ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- Third Party
- Y
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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