← Product Code [MOD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD) · K935788

# BICORE SMARTCATH INTRATRACHEAL CATHETER (K935788)

_Bicore Monitoring Systems · MOD · Jul 3, 1995 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K935788

## Device Facts

- **Applicant:** Bicore Monitoring Systems
- **Product Code:** [MOD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD.md)
- **Decision Date:** Jul 3, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5895
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K935788](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MOD/K935788)

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