← Product Code [CBZ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ) · K862114

# KHURI REGIONAL TISSUE PH MONITOR (K862114)

_Vascular Technology Incorporated · CBZ · Jun 25, 1986 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K862114

## Device Facts

- **Applicant:** Vascular Technology Incorporated
- **Product Code:** [CBZ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ.md)
- **Decision Date:** Jun 25, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1170
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K862114](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBZ/K862114)

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