510(k) K896526
K896526 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "LYTENING(TM) 5, LYTENING(TM) SYSTEM 30". The FDA issued a decision of Substantially Equivalent on Jan 2, 1990. 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
- Jan 2, 1990
- Date Received
- Nov 13, 1989
- 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)