Head and Neck Immobilization System, Body Immobilization System
FDA 510(k) K111340 · Medtec, Inc.
510(k) numberK111340
Submission
- Device name
- Head and Neck Immobilization System, Body Immobilization System
- Applicant
- Medtec, Inc.
Orange City, IA, US - Received
- May 12, 2011
- Decision date
- June 28, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Head and Neck Immobilization System, Body Immobilization System cleared by the FDA?
Head and Neck Immobilization System, Body Immobilization System (K111340) received a 510(k) decision of Substantially Equivalent on June 28, 2011, 47 days after the submission was received.
What is the product code of K111340?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.