← Product Code [CCE](/productcode/CCE) · K780850

# SEARLE NEONATAL OXYGEN PROBE (K780850)

_Will Ross Co. · CCE · Aug 23, 1978 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K780850

## Device Facts

- **Applicant:** Will Ross Co.
- **Product Code:** [CCE](/productcode/CCE.md)
- **Decision Date:** Aug 23, 1978
- **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/device/K780850](https://fda.innolitics.com/device/K780850)

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