Iris AirShuttle
FDA 510(k) K230312 · Qfix
510(k) numberK230312
Submission
- Device name
- Iris AirShuttle
- Applicant
- Qfix
Avondale, PA, US - Received
- February 3, 2023
- Decision date
- March 31, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K160627 | Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer…IYE · Traditional | 06/14/2016SE |
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Questions and answers
When was Iris AirShuttle cleared by the FDA?
Iris AirShuttle (K230312) received a 510(k) decision of Substantially Equivalent on March 31, 2023, 56 days after the submission was received.
What is the product code of K230312?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.