The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Eml105 Electrolyte Metabolite Analyzer.
| Device ID | K962334 |
| 510k Number | K962334 |
| Device Name: | EML105 ELECTROLYTE METABOLITE ANALYZER |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | RADIOMETER AMERICA, INC. 810 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Donald L Baker |
| Correspondent | Donald L Baker RADIOMETER AMERICA, INC. 810 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JFP |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1996-10-24 |
| Summary: | summary |