JEHClass II
Plethysmograph, Volume
21 CFR 868.1760 / Anesthesiology
JEH is the FDA product code for Plethysmograph, Volume, a class II device type, regulated under 21 CFR 868.1760. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- JEH
- Device name
- Plethysmograph, Volume
- Regulation
- 21 CFR 868.1760
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 11
- Ingested recalls
- 0
Clearances, product code JEH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 3 |
| 1997 | 1 |
| 2003 | 1 |
| 2008 | 1 |
| 2023 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code JEH| Applicant | Clearances |
|---|---|
| Erich Jaeger GmbH & Co. KG | 2 |
| Biometrix Ltd. | 1 |
| C.E. Diagnosis, Inc. | 1 |
| Cybermedic, Inc. | 1 |
| D. E. Hokanson, Inc. | 1 |
| Ganshorn Medizin Electronic GmbH | 1 |
| Jeneric/Pentron, Inc. | 1 |
| Morgan Scientific, Inc. | 1 |
| Viasys Healthcare GmbH | 1 |
| Vitalograph Ireland Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
