The following data is part of a premarket notification filed by Elitechgroup with the FDA for Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise Calibrators.
| Device ID | K111960 |
| 510k Number | K111960 |
| Device Name: | ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | ELITECHGROUP 21720 23RD DR SE SUITE 150 Bothell, WA 98021 |
| Contact | Debra K Hutson |
| Correspondent | Debra K Hutson ELITECHGROUP 21720 23RD DR SE SUITE 150 Bothell, WA 98021 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-11 |
| Decision Date | 2011-11-18 |
| Summary: | summary |