510(k) K112788
K112788 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASTLYTE NA/K/CA/PH". The FDA issued a decision of Substantially Equivalent on October 20, 2011. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Medica Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 2011
- Date Received
- September 26, 2011
- Clearance Type
- Special
- 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