ExSpiron 2Xi
K-Number: K192595 · 2019-12-17
ApplicantRespiratory Motion
Decision Date2019-12-17
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
ExSpiron 2Xi is a medical device manufactured by Respiratory Motion. It received FDA 510(k) clearance on 2019-12-17 under approval number K192595. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ExSpiron 2Xi?
ExSpiron 2Xi is a medical device that received FDA 510(k) clearance on 2019-12-17. It is manufactured by Respiratory Motion. The 510(k) number is K192595.
When was ExSpiron 2Xi approved by the FDA?
ExSpiron 2Xi received FDA 510(k) clearance on 2019-12-17, under approval number K192595.
What company makes ExSpiron 2Xi?
ExSpiron 2Xi is manufactured by Respiratory Motion.
What is the FDA product code for ExSpiron 2Xi?
The FDA product code for ExSpiron 2Xi is BZK.
Related Clinical Trials
NCT07373496
Patient Position Monitoring System for Beam Gated Radiation Therapy of Malignancies of the Chest and Upper Abdomen
RECRUITING
NCT02434809
Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Transponders to Reduce Target Position Uncertainty in Radiation Treatment of Lung Malignancies
ACTIVE_NOT_RECRUITING
Related Devices (Code: BZK)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.