PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)
FDA 510(k) K240706 · Ganshorn Medizin Electronic GmbH
510(k) numberK240706
Submission
- Device name
- PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)
- Applicant
- Ganshorn Medizin Electronic GmbH
Niederlauer, DE - Received
- March 14, 2024
- Decision date
- December 9, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JEH – Plethysmograph, Volume
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1760
- Specialty
- Anesthesiology
Other 510(k)s with product code JEH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223818 | Model 9160 VitaloQUBJEH · Traditional | Vitalograph Ireland, Ltd. | 05/25/2023SE |
| K072061 | Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT BodyJEH · Traditional | Viasys Healthcare GmbH | 04/22/2008SE |
| K022636 | Body Box 5500JEH · Traditional | Morgan Scientific, Inc. | 01/13/2003SE |
| K960840 | C.E. Vascular MachineJEH · Traditional | C.E. Diagnosis, Inc. | 03/28/1997SE |
| K953642 | AP-18JEH · Traditional | Jeneric/Pentron, Inc. | 12/12/1995SE |
| K951901 | Masterscreen PFT BodyJEH · Traditional | Erich Jaeger GmbH & Co. KG | 07/31/1995SE |
| K936108 | Masterscreen BodyJEH · Traditional | Erich Jaeger GmbH & Co. KG | 02/03/1995SE |
| K932812 | Ec 5R PlethysmographJEH · Traditional | D. E. Hokanson, Inc. | 01/13/1994SE |
| K925040 | TelepulseJEH · Traditional | Biometrix , Ltd. | 08/23/1993SE |
| K851197 | Cybermedic CM-810 Body PlethysmographJEH · Traditional | Cybermedic, Inc. | 07/08/1985SE |
More from Cybermedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160116 | SpiroScoutBZG · Traditional | 10/07/2016SE |
Questions and answers
When was PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) cleared by the FDA?
PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) (K240706) received a 510(k) decision of Substantially Equivalent on December 9, 2024, 270 days after the submission was received.
What is the product code of K240706?
The FDA product code is JEH – Plethysmograph, Volume, a Class II (moderate risk) device regulated under 21 CFR 868.1760.