Omni Modular, Omni C And Omni S Analyzer (ph Electrode)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050423 FDA 510(k)
- FDA Product Code
- CHL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1120 FDA 510(k)
- Regulation Number
- 862.1120 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OMNI Modular, OMNI C, and OMNI S Analyzers utilize a pH electrode to measure hydrogen ion (H+) concentration in pleural fluid. The device operates on the Sorensen 1909 principle using an H+ sensitive glass membrane and an Ag/AgCl reference electrode.
The device is supplied by Roche Diagnostics and is classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls. It received FDA 510(k) clearance with number K050423 on 2005-04-22, with a decision of Substantially Equivalent.
Frequently asked questions
What is the OMNI Modular pH Electrode Analyzer used for?
The OMNI Modular, OMNI C, and OMNI S Analyzers utilize a pH electrode to measure hydrogen ion (H+) concentration in pleural fluid. They operate on the Sorensen 1909 principle using an H+ sensitive glass membrane and an Ag/AgCl reference electrode.
How is the OMNI pH Electrode Analyzer supplied?
The device is supplied by Roche Diagnostics and is classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.
What is the regulatory status of the OMNI pH Electrode Analyzer?
The device received FDA 510(k) clearance with number K050423 on 2005-04-22, with a decision of Substantially Equivalent. It is classified under product code CHL and falls under Class II - Special Controls.
How does the OMNI pH Electrode Analyzer work?
The analyzer operates on the Sorensen 1909 principle, utilizing an H+ sensitive glass membrane and an Ag/AgCl reference electrode to measure hydrogen ion concentration in pleural fluid.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Omni Modular, Omni C and Omni S Analyzer (Ph Electrode), OMNI MODULAR, OMNI C AND OMNI S ANALYZE... (K050423) - FDA 510(k), OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050423 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K050423 24 fields · synced Sep 26, 2026