Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1870](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1870) → BXW — Calibrator, Volume, Gas

# BXW · Calibrator, Volume, Gas

_Anesthesiology · 21 CFR 868.1870 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXW

## Overview

- **Product Code:** BXW
- **Device Name:** Calibrator, Volume, Gas
- **Regulation:** [21 CFR 868.1870](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1870)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A gas volume calibrator is a device that is intended for medical purposes and that is used to calibrate the output of gas volume measurement instruments by delivering a known gas volume.

## Classification Rationale

Class I (general 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K853848](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXW/K853848.md) | RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR | Medical Graphics Corp. | Dec 5, 1985 | SESE |
| [K831758](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXW/K831758.md) | FLOW-CALIBRATION MODULE | The Perkin-Elmer Corp. | Jul 19, 1983 | SESE |
| [K830898](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXW/K830898.md) | SYRINGE 500BC BE #7000 | Instrumentation Industries, Inc. | May 16, 1983 | SESE |
| [K812765](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXW/K812765.md) | DATASCRIBE #DS-40 | Timeter Instrument Corp. | Nov 16, 1981 | SESE |
| [K810290](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXW/K810290.md) | OHIO CAL-CHEK | Ohio Medical Products | Feb 12, 1981 | SESE |
| [K760520](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXW/K760520.md) | CALIPERS, MCGAW SKINFOLD | Mcgaw Laboratories | Nov 12, 1976 | SESE |

## Top Applicants

- Instrumentation Industries, Inc. — 1 clearance
- Mcgaw Laboratories — 1 clearance
- Medical Graphics Corp. — 1 clearance
- Ohio Medical Products — 1 clearance
- The Perkin-Elmer Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXW](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BXW)

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