Khuri Regional Tissue Ph Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K862114 FDA 510(k)
- FDA Product Code
- CBZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1170 FDA 510(k)
- Regulation Number
- 868.1170 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Khuri Regional Tissue Ph Monitor is a device used for measuring hydrogen-ion concentration (pH) in tissue. It is classified as an analyzer, ion, hydrogen-ion (ph), blood-phase, indwelling device intended for use in anesthesiology.
This device is supplied by Vascular Technology Incorporated and is FDA 510(k) cleared with product code CBZ. It is a class II device with regulation number 868.1170 and was cleared on June 25, 1986. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.
Frequently asked questions
What is the Khuri Regional Tissue Ph Monitor used for?
The Khuri Regional Tissue Ph Monitor is designed for measuring hydrogen-ion concentration (pH) in tissue. It is classified as an analyzer, ion, hydrogen-ion (ph), blood-phase, indwelling device specifically intended for use in anesthesiology procedures.
How is the Khuri Regional Tissue Ph Monitor supplied?
The device is supplied by Vascular Technology Incorporated. The product information does not specify whether it is single-use or reusable, nor does it provide details about sterility or packaging configuration.
What is the regulatory status of the Khuri Regional Tissue Ph Monitor?
The Khuri Regional Tissue Ph Monitor is FDA 510(k) cleared with product code CBZ. It is classified as a class II device with regulation number 868.1170 and received clearance on June 25, 1986. The device was determined to be substantially equivalent to predicate devices.
Are there different sizes or models of the Khuri Regional Tissue Ph Monitor available?
The device data does not specify different sizes or models of the Khuri Regional Tissue Ph Monitor. The information provided only describes the basic device without mentioning variations in size, model numbers, or different configurations.
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: KHURI REGIONAL TISSUE PH MONITOR (K862114) — FDA 510 (k) | Innolitics, Khuri Regional Tissue Ph Monitor - Beudamed, Vascular-Technology-Inc FDA Filings - 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 | K862114 | Class II | Active |
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Manufacturer
- Manufacturer
- Vascular Technology Incorporated
Sources (1)
- FDA 510(k) K862114 24 fields · synced Sep 28, 2026