X-Ray System Xr-Mx
FDA 510(k) K004037 · Karl Storz Endoscopy
510(k) numberK004037
Submission
- Device name
- X-Ray System Xr-Mx
- Applicant
- Karl Storz Endoscopy
Culver City, CA, US - Received
- December 28, 2000
- Decision date
- February 2, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was X-Ray System Xr-Mx cleared by the FDA?
X-Ray System Xr-Mx (K004037) received a 510(k) decision of Substantially Equivalent on February 2, 2001, 36 days after the submission was received.
What is the product code of K004037?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.