MRI Patient Positioning Devices
FDA 510(k) K080072 · CIVCO Medical Instruments Co., Inc.
510(k) numberK080072
Submission
- Device name
- MRI Patient Positioning Devices
- Applicant
- CIVCO Medical Instruments Co., Inc.
Appollo Beach, FL, US - Received
- January 11, 2008
- Decision date
- June 4, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MRI Patient Positioning Devices cleared by the FDA?
MRI Patient Positioning Devices (K080072) received a 510(k) decision of Substantially Equivalent on June 4, 2008, 145 days after the submission was received.
What is the product code of K080072?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.