KEY RING ALCOHOL BREATHALYZER— 510(k) K082086
Substantially EquivalentThe Ashley Collection, Inc.
FDA 510(k) clearance K082086 for KEY RING ALCOHOL BREATHALYZER, Substantially Equivalent on 2008-12-19. Applicant: The Ashley Collection, Inc.. Device class: 1.
Clearance details
- Applicant
- The Ashley Collection, Inc.
- Product code
- Code DJZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.3050
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code DJZ
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