← Product Code [BZK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK) · K772016

# RESPITRACE (K772016)

_Respitrace Corp. · BZK · Jan 26, 1978 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K772016

## Device Facts

- **Applicant:** Respitrace Corp.
- **Product Code:** [BZK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK.md)
- **Decision Date:** Jan 26, 1978
- **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.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K772016](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K772016)

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