MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TY
FDA 510(k) K111237 · Nec Display Solutions , Ltd.
510(k) numberK111237
Submission
- Device name
- MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TY
- Applicant
- Nec Display Solutions , Ltd.
New Taipei City, TW - Received
- May 2, 2011
- Decision date
- June 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TY cleared by the FDA?
MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TY (K111237) received a 510(k) decision of Substantially Equivalent on June 15, 2011, 44 days after the submission was received.
What is the product code of K111237?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.