The following data is part of a premarket notification filed by Ionetics, Inc. with the FDA for Modified Sodium Electrode.
| Device ID | K863907 |
| 510k Number | K863907 |
| Device Name: | MODIFIED SODIUM ELECTRODE |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | IONETICS, INC. 3020 ENTERPRISE Costa Mesa, CA 92626 |
| Contact | Clark Westcott |
| Correspondent | Clark Westcott IONETICS, INC. 3020 ENTERPRISE Costa Mesa, CA 92626 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-07 |
| Decision Date | 1986-12-10 |