Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1900](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1900) → BZM — Calculator, Pulmonary Function Interpretor (Diagnostic)

# BZM · Calculator, Pulmonary Function Interpretor (Diagnostic)

_Anesthesiology · 21 CFR 868.1900 · Class 2_

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

## Overview

- **Product Code:** BZM
- **Device Name:** Calculator, Pulmonary Function Interpretor (Diagnostic)
- **Regulation:** [21 CFR 868.1900](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1900)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## Identification

A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 26)

Showing 20 most recent of 26 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K102229](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K102229.md) | PULMOTRACK 2020 SYSTEM | Karmelsonix | Mar 4, 2011 | SESE |
| [K090863](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K090863.md) | PERSONAL WHEEZOMETER | Karmelsonix | Sep 21, 2009 | SESE |
| [K071955](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K071955.md) | WIM-PC, MODEL 1010 | Karmelsonix | Nov 1, 2007 | SESE |
| [K012387](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K012387.md) | STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM | Stethographics, Inc. | Apr 23, 2002 | SESE |
| [K980878](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K980878.md) | PULMOTRACK,MODEL 1010 | Karmel Medical Acoustic Technologies , Ltd. | Dec 28, 1998 | SESE |
| [K974200](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K974200.md) | ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM | Orca Diagnostics Corp. | Jul 21, 1998 | SESE |
| [K955432](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K955432.md) | CPX, CCM, CATH WITH 15% CO2 | Medical Graphics Corp. | Jul 1, 1996 | SESE |
| [K923209](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K923209.md) | MEDGRAPHICS EXERCISE CONSULT | Medical Graphics Corp. | Mar 11, 1993 | SESE |
| [K911143](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K911143.md) | PB100 DIAGNOSTIC SPIROMETER | Puritan Bennett Corp. | Nov 29, 1991 | SESE |
| [K896345](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K896345.md) | EXERCISE EVALUATION SYSTEM 2010 | Medical Graphics Corp. | Jan 20, 1990 | SESE |
| [K880550](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K880550.md) | BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS | Medimicro Systems, Inc. | Jul 25, 1988 | SESE |
| [K874902](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K874902.md) | SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY | Gomi Medical Instruments | Jun 7, 1988 | SESE |
| [K871711](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K871711.md) | MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM | Medical Graphics Corp. | Sep 25, 1987 | SESE |
| [K864911](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K864911.md) | EXERSYSTEM(TM) MMC 5000 | Med Science | Aug 21, 1987 | SESE |
| [K864885](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K864885.md) | SPIROVISION | Futuremed Div. of Future Impex Corp. | Jan 15, 1987 | SESE |
| [K863953](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K863953.md) | SPIROMETRICS MODEL 2500 FLOWMATE(TM) | Spirometrics, Inc. | Jan 15, 1987 | SESE |
| [K861929](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K861929.md) | PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070 | Medical Graphics Corp. | Sep 26, 1986 | SN |
| [K853190](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K853190.md) | SUPERSPIRO | Cdx Corp. | Sep 26, 1985 | SESE |
| [K851706](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K851706.md) | UNIVERSAL COMPUTER INTERFACE SYSTEM | Vacumetrics, Inc. | May 3, 1985 | SESE |
| [K842782](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K842782.md) | PHYSIOLOGICAL ANALYZER CM-710 | Cybermedic, Inc. | Aug 17, 1984 | SESE |

## Top Applicants

- Medical Graphics Corp. — 7 clearances
- Karmelsonix — 3 clearances
- Cdx Corp. — 2 clearances
- Cybermedic, Inc. — 2 clearances
- Cavitron Corp. — 1 clearance

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

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