Scintillating Fiber Dosimeter (SFD), Model MT-SFD-1000
FDA 510(k) K021360 · Med-Tec,Inc.
510(k) numberK021360
Submission
- Device name
- Scintillating Fiber Dosimeter (SFD), Model MT-SFD-1000
- Applicant
- Med-Tec,Inc.
Orange City, IA, US - Received
- April 30, 2002
- Decision date
- June 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Scintillating Fiber Dosimeter (SFD), Model MT-SFD-1000 cleared by the FDA?
Scintillating Fiber Dosimeter (SFD), Model MT-SFD-1000 (K021360) received a 510(k) decision of Substantially Equivalent on June 10, 2003, 406 days after the submission was received.
What is the product code of K021360?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.