← Product Code [BZQ](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ) · K823563

# EEG & RESPIRATION MODULES POLYGRAPH (K823563)

_Nihon Kohden America, Inc. · BZQ · Jan 12, 1983 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ/K823563

## Device Facts

- **Applicant:** Nihon Kohden America, Inc.
- **Product Code:** [BZQ](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ.md)
- **Decision Date:** Jan 12, 1983
- **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/K823563](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ/K823563)

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