Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1760](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1760) → JEH — Plethysmograph, Volume

# JEH · Plethysmograph, Volume

_Anesthesiology · 21 CFR 868.1760 · Class 2_

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

## Overview

- **Product Code:** JEH
- **Device Name:** Plethysmograph, Volume
- **Regulation:** [21 CFR 868.1760](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1760)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## Identification

A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K240706](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEH/K240706.md) | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) | Ganshorn Medizin Electronic GmbH | Dec 9, 2024 | SESE |
| [K223818](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEH/K223818.md) | Model 9160 VitaloQUB | Vitalograph Ireland, Ltd. | May 25, 2023 | SESE |
| [K072061](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEH/K072061.md) | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY | Viasys Healthcare GmbH | Apr 22, 2008 | SESE |
| [K022636](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEH/K022636.md) | BODY BOX 5500 | Morgan Scientific, Inc. | Jan 13, 2003 | SESE |
| [K960840](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEH/K960840.md) | C.E. VASCULAR MACHINE | C.E. Diagnosis, Inc. | Mar 28, 1997 | SESE |
| [K953642](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEH/K953642.md) | AP-18 | Jeneric/Pentron, Inc. | Dec 12, 1995 | SESE |
| [K951901](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEH/K951901.md) | MASTERSCREEN PFT BODY | Erich Jaeger GmbH & Co. KG | Jul 31, 1995 | SESE |
| [K936108](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEH/K936108.md) | MASTERSCREEN BODY | Erich Jaeger GmbH & Co. KG | Feb 3, 1995 | SESE |
| [K932812](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEH/K932812.md) | EC 5R PLETHYSMOGRAPH | D. E. Hokanson, Inc. | Jan 13, 1994 | SESE |
| [K925040](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEH/K925040.md) | TELEPULSE | Biometrix , Ltd. | Aug 23, 1993 | SESE |
| [K851197](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/JEH/K851197.md) | CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH | Cybermedic, Inc. | Jul 8, 1985 | SESE |

## Top Applicants

- Erich Jaeger GmbH & Co. KG — 2 clearances
- Biometrix , Ltd. — 1 clearance
- C.E. Diagnosis, Inc. — 1 clearance
- Cybermedic, Inc. — 1 clearance
- D. E. Hokanson, Inc. — 1 clearance

---

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

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