← Product Code [BYT](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT) · K903745

# THE HAYEK OSCILLATOR (K903745)

_Flexco Medical Instruments · BYT · Nov 9, 1990 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K903745

## Device Facts

- **Applicant:** Flexco Medical Instruments
- **Product Code:** [BYT](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT.md)
- **Decision Date:** Nov 9, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5935
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K903745](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K903745)

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