← Product Code [BZK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK) · K830995

# POCKET SPIROMETER (K830995)

_P.K. Morgan Instruments, Inc. · BZK · Apr 28, 1983 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K830995

## Device Facts

- **Applicant:** P.K. Morgan Instruments, Inc.
- **Product Code:** [BZK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK.md)
- **Decision Date:** Apr 28, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1850
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K830995](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K830995)

**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