Product Code: JEH FDA class 2 21 CFR 868.1760

Plethysmograph, Volume

Anesthesiology

A Volume Plethysmograph is a device used to measure changes in the volume of body parts or organs, most commonly employed to assess lung volumes, airway resistance, and pulmonary function in respiratory medicine and anesthesiology. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, requiring 510(k) premarket notification. The product code is JEH, regulated under 21 CFR 868.1760, within the Anesthesiology medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: JEH
Device Class: FDA class 2
Regulation Number: 868.1760
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 11 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240706	PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)	Dec 09, 2024	Substantially Equivalent	Ganshorn Medizin Electronic GmbH
K223818	Model 9160 VitaloQUB	May 25, 2023	Substantially Equivalent	Vitalograph Ireland, Ltd.
K072061	MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY	Apr 22, 2008	Substantially Equivalent	Viasys Healthcare GmbH
K022636	BODY BOX 5500	Jan 13, 2003	Substantially Equivalent	Morgan Scientific, Inc.
K960840	C.E. VASCULAR MACHINE	Mar 28, 1997	Substantially Equivalent	C.E. Diagnosis, Inc.
K953642	AP-18	Dec 12, 1995	Substantially Equivalent	Jeneric/Pentron, Inc.
K951901	MASTERSCREEN PFT BODY	Jul 31, 1995	Substantially Equivalent	Erich Jaeger GmbH & Co. KG
K936108	MASTERSCREEN BODY	Feb 03, 1995	Substantially Equivalent	Erich Jaeger GmbH & Co. KG
K932812	EC 5R PLETHYSMOGRAPH	Jan 13, 1994	Substantially Equivalent	D. E. Hokanson, Inc.
K925040	TELEPULSE	Aug 23, 1993	Substantially Equivalent	Biometrix , Ltd.
K851197	CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH	Jul 08, 1985	Substantially Equivalent	Cybermedic, Inc.