K910554 is an FDA 510(k) clearance for the CLINAK(TM) ISE SUBSYSTEM. This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on March 6, 1991, 34 days after receiving the submission on January 31, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K910554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 1991 |
| Decision Date | March 06, 1991 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGS — Electrode, Ion Specific, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |