Data / Medical devices / Plethysmograph, Volume
Plethysmograph, Volume (JEH): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make Plethysmograph, Volume (product code JEH, Class 2, 21 CFR 868.1760). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on December 9, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JEH
- Device class
- 2
- Regulation
- 868.1760
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| Germany | 3 |
| Belgium | 1 |
| Ireland | 1 |
| Mexico | 1 |
Makers of Plethysmograph, Volume
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Jaeger Medical GmbH | HOECHBERG Bavaria, Germany | Complaint file establishment, Manufacturer | 2 | April 22, 2008 | 0 | 0 | 0 | api.fda.gov |
| Ganshorn Medizin Electronic GMBH | Bad Neustadt Bavaria, Germany | Manufacturer | 1 | December 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medisoft S.A. | DINANT Namur, Belgium | Manufacturer | 1 | January 13, 2003 | 0 | 0 | 0 | api.fda.gov |
| Vitalograph Ireland Ltd. | Co Clare, Ireland | Manufacturer | 1 | May 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| eResearchTechnology GmbH | Estenfeld Bavaria, Germany | Complaint file establishment, Manufacturer | 1 | July 31, 1995 | 0 | 0 | 0 | api.fda.gov |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.