The following data is part of a premarket notification filed by Elitechgroup Vital Scientific Bv with the FDA for Elitech Clinical Systems Selectra Prom/elical 2/elitrol I And Elitrol Ii/ast/got 4+1 Sl/potassium, Sodium, Chloride....
| Device ID | K102647 |
| 510k Number | K102647 |
| Device Name: | ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | ELITECHGROUP VITAL SCIENTIFIC BV 21720 23RD DR SE SUITE 150 Bothell, WA 98021 |
| Contact | Debra K Hutson |
| Correspondent | Debra K Hutson ELITECHGROUP VITAL SCIENTIFIC BV 21720 23RD DR SE SUITE 150 Bothell, WA 98021 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CIT |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-14 |
| Decision Date | 2011-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661540600418 | K102647 | 000 |
| 03661540600401 | K102647 | 000 |
| 03661540600395 | K102647 | 000 |
| 03661540600357 | K102647 | 000 |