Non-Invasive Patient Fixation System
FDA 510(k) K023449 · Stryker Leibinger
510(k) numberK023449
Submission
- Device name
- Non-Invasive Patient Fixation System
- Applicant
- Stryker Leibinger
Kalamazoo, MI, US - Received
- October 15, 2002
- Decision date
- January 13, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Non-Invasive Patient Fixation System cleared by the FDA?
Non-Invasive Patient Fixation System (K023449) received a 510(k) decision of Substantially Equivalent on January 13, 2003, 90 days after the submission was received.
What is the product code of K023449?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.