← Product Code [BZQ](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ) · K792528

# RESPIRATION/APNEA AMPLIFIER MODEL 3105 (K792528)

_Electronics For Medicine, Inc. · BZQ · Feb 21, 1980 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ/K792528

## Device Facts

- **Applicant:** Electronics For Medicine, Inc.
- **Product Code:** [BZQ](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ.md)
- **Decision Date:** Feb 21, 1980
- **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/K792528](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BZQ/K792528)

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