← Product Code [CCE](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCE) · K890624

# TISSUE OXYGEN MONITOR SYSTEM, MODEL II (K890624)

_Baxter Healthcare Corp · CCE · Dec 22, 1989 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCE/K890624

## Device Facts

- **Applicant:** Baxter Healthcare Corp
- **Product Code:** [CCE](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCE.md)
- **Decision Date:** Dec 22, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1200
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

An indwelling blood oxygen partial pressure (PO2 ) analyzer is a device that consists of a catheter-tip PO2 transducer (e.g., PO2 electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.

## 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/CCE/K890624](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCE/K890624)

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