← Product Code [BZQ](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ) · K905575

# MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON (K905575)

_Edentec Corp. · BZQ · Jun 20, 1991 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ/K905575

## Device Facts

- **Applicant:** Edentec Corp.
- **Product Code:** [BZQ](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ.md)
- **Decision Date:** Jun 20, 1991
- **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/K905575](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ/K905575)

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