← Product Code [BXA](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXA) · K771510

# SERVO-PAK MOLEL 0030 (K771510)

_Isothermal Systems, Inc. · BXA · Aug 16, 1977 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXA/K771510

## Device Facts

- **Applicant:** Isothermal Systems, Inc.
- **Product Code:** [BXA](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXA.md)
- **Decision Date:** Aug 16, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1975
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A water vapor analyzer is a device intended to measure the concentration of water vapor in a patient's expired gases by using techniques such as mass spectrometry.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXA/K771510](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXA/K771510)

**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
