← Product Code [BZQ](/productcode/BZQ) · K790304

# PREAMPLIFIER MODULE, EKG RESPIRATION (K790304)

_Abbott Medical Electronics Co. · BZQ · Feb 27, 1979 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K790304

## Device Facts

- **Applicant:** Abbott Medical Electronics Co.
- **Product Code:** [BZQ](/productcode/BZQ.md)
- **Decision Date:** Feb 27, 1979
- **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.

---

**Source:** [https://fda.innolitics.com/device/K790304](https://fda.innolitics.com/device/K790304)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
