FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POCKET BREATHALYZER. CONNECTABLES
K Number: K052448
·
Decision Feb 23, 2006
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
27
Applicant Total
1
Review Days
169
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- POCKET BREATHALYZER. CONNECTABLES
- K Number
- K052448
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3050
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Connectables, LLC
- Date Received
- September 7, 2005
- Decision Date
- February 23, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DJZ), ordered by most recent decision date.
Soberlink Cellular Device and Sober Sky Web Portal
FDA 510(k)
FDA Class 1
·Clinical Toxicology
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
FDA 510(k)
FDA Class 1
·Clinical Toxicology
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
FDA 510(k)
FDA Class 1
·Clinical Toxicology
BREATHSCN PRO
FDA 510(k)
FDA Class 1
·Clinical Toxicology
CONTRALCO
FDA 510(k)
FDA Class 1
·Clinical Toxicology