Revolution Ascend Sliding
FDA 510(k) K233749 · Ge Hangwei Medical Systems Co., Ltd.
510(k) numberK233749
Submission
- Device name
- Revolution Ascend Sliding
- Applicant
- Ge Hangwei Medical Systems Co., Ltd.
Beijing Economic & Technological Develop, CN - Received
- November 22, 2023
- Decision date
- February 22, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Revolution Ascend Sliding cleared by the FDA?
Revolution Ascend Sliding (K233749) received a 510(k) decision of Substantially Equivalent on February 22, 2024, 92 days after the submission was received.
What is the product code of K233749?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.