← Product Code [BSE](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BSE) · K841858

# SPIROLOOP (K841858)

_Datamed, Inc. · BSE · Jul 11, 1984 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BSE/K841858

## Device Facts

- **Applicant:** Datamed, Inc.
- **Product Code:** [BSE](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BSE.md)
- **Decision Date:** Jul 11, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1640
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BSE/K841858](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BSE/K841858)

**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