← Product Code [BZG](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG) · K913396

# CANNULA STYLE THERMOCOUPLES (K913396)

_Pro-Tech, Inc. · BZG · May 22, 1992 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K913396

## Device Facts

- **Applicant:** Pro-Tech, Inc.
- **Product Code:** [BZG](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG.md)
- **Decision Date:** May 22, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1840
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K913396](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K913396)

**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
