K240706 is an FDA 510(k) clearance for the PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+). This device is classified as a Plethysmograph, Volume (Class II - Special Controls, product code JEH).
Submitted by Ganshorn Medizin Electronic GmbH (Niederlauer, DE). The FDA issued a Cleared decision on December 9, 2024, 270 days after receiving the submission on March 14, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1760.
| 510(k) Number | K240706 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2024 |
| Decision Date | December 09, 2024 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | JEH — Plethysmograph, Volume |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1760 |