← Product Code [JEG](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEG) · K880442

# BRUSHRITE (K880442)

_Pro Care Laboratories, Inc. · JEG · May 16, 1988 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEG/K880442

## Device Facts

- **Applicant:** Pro Care Laboratories, Inc.
- **Product Code:** [JEG](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEG.md)
- **Decision Date:** May 16, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1075
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

An argon gas analyzer is a device intended to measure the concentration of argon in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as mass spectrometry or thermal conductivity.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEG/K880442](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEG/K880442)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
