FDA 510(k)

Iris AirShuttle

K-Number: K230312 · 2023-03-31

ApplicantQfix

Decision Date2023-03-31

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Iris AirShuttle is a medical device manufactured by Qfix. It received FDA 510(k) clearance on 2023-03-31 under approval number K230312. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Iris AirShuttle?

Iris AirShuttle is a medical device that received FDA 510(k) clearance on 2023-03-31. It is manufactured by Qfix. The 510(k) number is K230312.

When was Iris AirShuttle approved by the FDA?

Iris AirShuttle received FDA 510(k) clearance on 2023-03-31, under approval number K230312.

What company makes Iris AirShuttle?

Iris AirShuttle is manufactured by Qfix.

What is the FDA product code for Iris AirShuttle?

The FDA product code for Iris AirShuttle is IYE.

Other Devices by Qfix

K160627Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories K182189Encompass SRS Headframe ; Encompass MR SRS Headframe K190668Encompass 15 Channel Head Coil, 3T K193243Alta Multipurpose Device

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.