← Product Code [JAX](/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX) · K833265

# RESPIRATORY FLOW MODULE (K833265)

_Thoratec Laboratories Corp. · JAX · Nov 28, 1983 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K833265

## Device Facts

- **Applicant:** Thoratec Laboratories Corp.
- **Product Code:** [JAX](/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX.md)
- **Decision Date:** Nov 28, 1983
- **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.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K833265](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K833265)

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