510(k) K910554
K910554 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CLINAK(TM) ISE SUBSYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 6, 1991. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 6, 1991
- Date Received
- Jan 31, 1991
- 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
- 510(k)