

# LSZ · Ventilator, High Frequency

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/AN-misc/LSZ

## Overview

- **Product Code:** LSZ
- **Device Name:** Ventilator, High Frequency
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P890034](https://fda.innolitics.com/submissions/AN/AN-misc/LSZ/P890034.md) | MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR | Covidien | Dec 13, 1991 | APWD |
| [P890057](https://fda.innolitics.com/submissions/AN/AN-misc/LSZ/P890057.md) | MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR | ZOLL Medical Corporation | Mar 29, 1991 | APPR |
| [P880013](https://fda.innolitics.com/submissions/AN/AN-misc/LSZ/P880013.md) | INFANT STAR HIGH FREQUENCY VENTILATOR | Nellcor Puritan Bennett, Inc. | Jan 19, 1990 | APWD |
| [P850064](https://fda.innolitics.com/submissions/AN/AN-misc/LSZ/P850064.md) | MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR | Bunnell, Inc. | Jun 30, 1988 | APPR |

## Top Applicants

- Bunnell, Inc. — 1 clearance
- Covidien — 1 clearance
- Nellcor Puritan Bennett, Inc. — 1 clearance
- ZOLL Medical Corporation — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/AN/AN-misc/LSZ](https://fda.innolitics.com/submissions/AN/AN-misc/LSZ)

**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
