JEH
11 FDA 510(k) clearances · Product code
218 daysmedian time to decision
393 days90th percentile
11clearances measured
FDA profile
- Official device name
- Plethysmograph, Volume
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1760
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 1 · 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) (K240706) | Ganshorn Medizin Electronic GmbH | 2024-12-09 |
| Model 9160 VitaloQUB (K223818) | Vitalograph Ireland, Ltd. | 2023-05-25 |
| MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY (K072061) | Viasys Healthcare GmbH | 2008-04-22 |
| BODY BOX 5500 (K022636) | Morgan Scientific, Inc. | 2003-01-13 |
| C.E. VASCULAR MACHINE (K960840) | C.E. Diagnosis, Inc. | 1997-03-28 |
| AP-18 (K953642) | Jeneric/Pentron, Inc. | 1995-12-12 |
| MASTERSCREEN PFT BODY (K951901) | Erich Jaeger GmbH & Co. KG | 1995-07-31 |
| MASTERSCREEN BODY (K936108) | Erich Jaeger GmbH & Co. KG | 1995-02-03 |
| EC 5R PLETHYSMOGRAPH (K932812) | D. E. Hokanson, Inc. | 1994-01-13 |
| TELEPULSE (K925040) | Biometrix , Ltd. | 1993-08-23 |
| CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH (K851197) | Cybermedic, Inc. | 1985-07-08 |
Track JEH automatically
Every clearance here is in the API, with alerts when new ones post.