510(k) K110520
K110520 is an FDA 510(k) premarket notification submitted by Tokyo Boeki Medisys, Inc. for the device "BIOLIS 12I". The FDA issued a decision of Substantially Equivalent on March 23, 2012. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Tokyo Boeki Medisys, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2012
- Date Received
- February 23, 2011
- 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