JEH · Plethysmograph, Volume
Anesthesiology · 21 CFR 868.1760 · Class 2
Overview
| Product Code | JEH |
|---|---|
| Device Name | Plethysmograph, Volume |
| Regulation | 21 CFR 868.1760 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) | Ganshorn Medizin Electronic GmbH | Dec 9, 2024 | SESE |
| K223818 | Model 9160 VitaloQUB | Vitalograph Ireland, Ltd. | May 25, 2023 | SESE |
| K072061 | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY | Viasys Healthcare GmbH | Apr 22, 2008 | SESE |
| K022636 | BODY BOX 5500 | Morgan Scientific, Inc. | Jan 13, 2003 | SESE |
| K960840 | C.E. VASCULAR MACHINE | C.E. Diagnosis, Inc. | Mar 28, 1997 | SESE |
| K953642 | AP-18 | Jeneric/Pentron, Inc. | Dec 12, 1995 | SESE |
| K951901 | MASTERSCREEN PFT BODY | Erich Jaeger GmbH & Co. KG | Jul 31, 1995 | SESE |
| K936108 | MASTERSCREEN BODY | Erich Jaeger GmbH & Co. KG | Feb 3, 1995 | SESE |
| K932812 | EC 5R PLETHYSMOGRAPH | D. E. Hokanson, Inc. | Jan 13, 1994 | SESE |
| K925040 | TELEPULSE | Biometrix , Ltd. | Aug 23, 1993 | SESE |
| K851197 | 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
