← Product Code [BYT](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT) · K860692

# PTR MK II VENTILATOR (K860692)

_Bear Medical Systems, Inc. · BYT · May 21, 1986 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K860692

## Device Facts

- **Applicant:** Bear Medical Systems, Inc.
- **Product Code:** [BYT](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT.md)
- **Decision Date:** May 21, 1986
- **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/K860692](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYT/K860692)

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