Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1750](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1750) → CCM — Plethysmograph, Pressure

# CCM · Plethysmograph, Pressure

_Anesthesiology · 21 CFR 868.1750 · Class 2_

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

## Overview

- **Product Code:** CCM
- **Device Name:** Plethysmograph, Pressure
- **Regulation:** [21 CFR 868.1750](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1750)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## Identification

A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K081823](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCM/K081823.md) | MASTERSCREEN PAED - BABY BODY | Viasys Healthcare GmbH | May 18, 2009 | SESE |
| [K023796](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCM/K023796.md) | MS PAED-BABY BODY | Erich Jaeger GmbH | Mar 3, 2003 | SESE |
| [K943259](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCM/K943259.md) | 1085 ULTIMATE E PLETHYSMOGRAPH | Medical Graphics Corp. | Apr 10, 1995 | SESE |
| [K893420](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCM/K893420.md) | MASTERLAB PFT AND MASTERLAB BODY BOX | Quinton, Inc. | Jun 23, 1989 | SESE |
| [K853390](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCM/K853390.md) | INFANT BODY TEST | Erich Jaeger, Inc. | Feb 5, 1986 | SESE |
| [K852102](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCM/K852102.md) | COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM | Warren E. Collins, Inc. | Jul 31, 1985 | SESE |
| [K852088](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCM/K852088.md) | SYSTEM 1085 BODY PLETHYSMOGRAPH | Medical Graphics Corp. | Jul 30, 1985 | SESE |
| [K843851](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCM/K843851.md) | BODYSCREEN II | Erich Jaeger, Inc. | Feb 14, 1985 | SESE |
| [K843846](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCM/K843846.md) | UNIVERSAL-BODYTEST | Erich Jaeger, Inc. | Feb 14, 1985 | SESE |
| [K791705](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCM/K791705.md) | 4200 PNEUMATIC MOUTH SHUTTER | Hans Rudolph, Inc. | Oct 4, 1979 | SESE |
| [K772367](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCM/K772367.md) | CHEST BELLOWS, SMALL | Honeywell, Inc. | Jan 11, 1978 | SESE |

## Top Applicants

- Erich Jaeger, Inc. — 3 clearances
- Medical Graphics Corp. — 2 clearances
- Erich Jaeger GmbH — 1 clearance
- Hans Rudolph, Inc. — 1 clearance
- Honeywell, Inc. — 1 clearance

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

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