GR40CW
FDA 510(k) K153401 · Samsung Electronics Co., Ltd.
510(k) numberK153401
Submission
- Device name
- GR40CW
- Applicant
- Samsung Electronics Co., Ltd.
Suwon-Si,, KR - Received
- November 24, 2015
- Decision date
- December 21, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was GR40CW cleared by the FDA?
GR40CW (K153401) received a 510(k) decision of Substantially Equivalent on December 21, 2015, 27 days after the submission was received.
What is the product code of K153401?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.