510(k) K121012
K121012 is an FDA 510(k) premarket notification submitted by Inpeco S.P.A. for the device "FLEXLAB 3.6, ACCELERATOR A3600". The FDA issued a decision of Substantially Equivalent on August 31, 2012. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2012
- Date Received
- April 3, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Potassium
- Device Class
- Class II
- Regulation Number
- 862.1600
- Review Panel
- CH
- Submission Type