K240706

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)

510(k) number
K240706
Device name
PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)
Applicant
Ganshorn Medizin Electronic GmbH DE
Product code
JEH — Plethysmograph, Volume
Decision date
2024-12-09
Date received
2024-03-14
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Anesthesiology
510(k) Summary (official FDA PDF): K240706.pdf
Official FDA record: K240706
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.