← Product Code [CCC](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCC) · K901548

# BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (K901548)

_Shiley, Inc. · CCC · Jan 14, 1991 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCC/K901548

## Device Facts

- **Applicant:** Shiley, Inc.
- **Product Code:** [CCC](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCC.md)
- **Decision Date:** Jan 14, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1150
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide 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/CCC/K901548](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCC/K901548)

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