← Product Code [JAX](/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX) · K853085

# PAX METER (K853085)

_Peace Medical, Inc. · JAX · Sep 3, 1985 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K853085

## Device Facts

- **Applicant:** Peace Medical, Inc.
- **Product Code:** [JAX](/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX.md)
- **Decision Date:** Sep 3, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.2550
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A pneumotachometer is a device intended for medical purposes that is used to determine gas flow by measuring the pressure differential across a known resistance. The device may use a set of capillaries or a metal screen for the resistive element.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K853085](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K853085)

**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