Product code JEH
- Device name
- Plethysmograph, Volume
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1760
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240706 | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) | Ganshorn Medizin Electronic GmbH | 2024-12-09 |
| K223818 | Model 9160 VitaloQUB | Vitalograph Ireland, Ltd. | 2023-05-25 |
| K072061 | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY | Viasys Healthcare GmbH | 2008-04-22 |
| K022636 | BODY BOX 5500 | Morgan Scientific, Inc. | 2003-01-13 |
| K960840 | C.E. VASCULAR MACHINE | C.E. Diagnosis, Inc. | 1997-03-28 |
| K953642 | AP-18 | Jeneric/Pentron, Inc. | 1995-12-12 |
| K951901 | MASTERSCREEN PFT BODY | Erich Jaeger GmbH & Co. KG | 1995-07-31 |
| K936108 | MASTERSCREEN BODY | Erich Jaeger GmbH & Co. KG | 1995-02-03 |
| K932812 | EC 5R PLETHYSMOGRAPH | D. E. Hokanson, Inc. | 1994-01-13 |
| K925040 | TELEPULSE | Biometrix , Ltd. | 1993-08-23 |
| K851197 | CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH | Cybermedic, Inc. | 1985-07-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04250892908731 | Jaeger | Jaeger Medical GmbH | 2025-11-24 |
| 04250892908816 | Jaeger | Jaeger Medical GmbH | 2025-11-24 |
| 04250892908861 | Jaeger | Jaeger Medical GmbH | 2025-11-24 |
| 04250892908304 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 04250892908311 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 04250892908328 | Jaeger | Jaeger Medical GmbH | 2025-10-31 |
| 14250892909117 | Jaeger | Jaeger Medical GmbH | 2025-08-11 |
| 07613365501254 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501247 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501230 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501223 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501216 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501193 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501209 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365500400 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365500301 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365500431 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365501018 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365501032 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365501070 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365501094 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 05099169916104 | VitaloQUB | VITALOGRAPH (IRELAND) LIMITED | 2023-06-09 |
| 14250892903900 | Vyaire | Jaeger Medical GmbH | 2021-04-01 |
| 14250892903917 | Vyaire | Jaeger Medical GmbH | 2021-04-01 |
| 14250892903726 | Vyaire | Jaeger Medical GmbH | 2021-04-01 |
| 04250892905693 | Vyaire | Jaeger Medical GmbH | 2021-01-21 |
| 14250892905799 | Vyaire | Jaeger Medical GmbH | 2021-01-21 |
| 04250892904689 | Vyaire | Jaeger Medical GmbH | 2019-10-14 |
| 04250892904672 | Vyaire | Jaeger Medical GmbH | 2019-10-14 |
| 00841494103866 | MEDI-FRIG | Cynosure, LLC | 2016-09-21 |