510(k) K043188
K043188 is an FDA 510(k) premarket notification submitted by Q3 Innovations, LLC for the device "ALCOHAWK PRECISION". The FDA issued a decision of Substantially Equivalent on February 9, 2005. The device falls under product code DJZ (Devices, Breath Trapping, Alcohol), a Class I device regulated under 21 CFR 862.3050. Q3 Innovations, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2005
- Date Received
- November 17, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Devices, Breath Trapping, Alcohol
- Device Class
- Class I
- Regulation Number
- 862.3050
- Review Panel
- TX
- Submission Type