The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Ionometer Eh.
| Device ID | K901039 |
| 510k Number | K901039 |
| Device Name: | IONOMETER EH |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Contact | Thomas E Cane |
| Correspondent | Thomas E Cane FRESENIUS USA, INC. 4090 PIKE LN. Concord, CA 94520 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-06 |
| Decision Date | 1990-06-28 |