← Product Code [BZQ](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ) · K891486

# AR-800PA RESPIRATION MODULE (K891486)

_Nihon Kohden America, Inc. · BZQ · Oct 24, 1989 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ/K891486

## Device Facts

- **Applicant:** Nihon Kohden America, Inc.
- **Product Code:** [BZQ](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ.md)
- **Decision Date:** Oct 24, 1989
- **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/K891486](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ/K891486)

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