510(k) K093143
K093143 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "MISSION BREATH ALCOHOL DETECTOR". The FDA issued a decision of Substantially Equivalent on January 28, 2010. The device falls under product code DJZ (Devices, Breath Trapping, Alcohol), a Class I device regulated under 21 CFR 862.3050. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 2010
- Date Received
- October 5, 2009
- 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