510(k) K863907
K863907 is an FDA 510(k) premarket notification submitted by Ionetics, Inc. for the device "MODIFIED SODIUM ELECTRODE". The FDA issued a decision of Substantially Equivalent on December 10, 1986. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Ionetics, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1986
- Date Received
- October 7, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Sodium
- Device Class
- Class II
- Regulation Number
- 862.1665
- Review Panel
- CH
- Submission Type