← Product Code [CBK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK) · K853760

# ADULT VENTILATOR TESTER VT-1 (K853760)

_Bio-Tek Instruments, Inc. · CBK · Dec 3, 1985 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K853760

## Device Facts

- **Applicant:** Bio-Tek Instruments, Inc.
- **Product Code:** [CBK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK.md)
- **Decision Date:** Dec 3, 1985
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K853760](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CBK/K853760)

**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