← Product Code [BZQ](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ) · K923402

# CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR (K923402)

_Pro-Tech, Inc. · BZQ · Dec 30, 1992 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ/K923402

## Device Facts

- **Applicant:** Pro-Tech, Inc.
- **Product Code:** [BZQ](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ.md)
- **Decision Date:** Dec 30, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.2375
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ/K923402](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ/K923402)

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