Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2550](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2550) → JAX — Pneumotachometer

# JAX · Pneumotachometer

_Anesthesiology · 21 CFR 868.2550 · Class 2_

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

## Overview

- **Product Code:** JAX
- **Device Name:** Pneumotachometer
- **Regulation:** [21 CFR 868.2550](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2550)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K990962](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K990962.md) | FLOSENSE, MODEL 29-8010 | Sdi Diagnostics, Inc. | Jan 7, 2000 | SESE |
| [K921178](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K921178.md) | PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS | Medical Associated Services, Inc. | Aug 26, 1992 | SESE |
| [K884464](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K884464.md) | SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR | Spirometrics, Inc. | Jan 19, 1989 | SESE |
| [K853085](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K853085.md) | PAX METER | Peace Medical, Inc. | Sep 3, 1985 | SESE |
| [K833265](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K833265.md) | RESPIRATORY FLOW MODULE | Thoratec Laboratories Corp. | Nov 28, 1983 | SESE |
| [K812825](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K812825.md) | FLO-COR I | Biotrine Corp. | Oct 26, 1981 | SESE |
| [K791730](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K791730.md) | RING-ORIFICE, TURBULENT FLOW PNEUMOT | Research Development Corp. | Nov 16, 1979 | SESE |
| [K770061](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/JAX/K770061.md) | VO RESPIRATORY PNEUMOTACHOGRAPH | Research Development Corp. | Jan 14, 1977 | SESE |

## Top Applicants

- Research Development Corp. — 2 clearances
- Biotrine Corp. — 1 clearance
- Medical Associated Services, Inc. — 1 clearance
- Peace Medical, Inc. — 1 clearance
- Sdi Diagnostics, Inc. — 1 clearance

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

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