Stat Profile pHOx Basic Analyzer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K013729 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 Stat Profile pHOx Basic Analyzer is a point-of-care device classified as an Electrode Measurement, Blood-Gases (Pco₂, Po₂) and Blood pH instrument. It measures partial pressures of carbon dioxide (Pco₂) and oxygen (Po₂), as well as blood pH levels, enabling rapid clinical assessment of patient gas exchange and acid-base balance. Designed for high-throughput clinical chemistry applications, it supports critical care and emergency settings where timely diagnostic results are essential.
This analyzer is intended for single-use or reusable configurations, depending on component specifications, and is regulated under FDA 510(k) clearance with a classification of Class II. Supplied as a modular system, it operates in clinical chemistry laboratories, intensive care units, and emergency departments. Sterility and MRI safety are not specified in the regulatory data, though its design adheres to FDA 510(k) K013729 and regulation number 862.1120 for electrode-based blood gas analyzers. No additional storage or handling instructions are provided beyond standard medical device protocols.
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: Stat - Wiley Online Library, NOVA BIOMEDICAL Stat Profile pHOx Service Manual, Stat Profile® | Nova Biomedical, Nova Biomedical Stat Profile pHOx Basic Manuals / Documents, Nova biomedical Stat Profile pHOx Manuals | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013729 | Class II | Active |
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Manufacturer
- Manufacturer
- Nova Biomedical Corp.
Sources (1)
- FDA 510(k) K013729 24 fields · synced Oct 1, 2026