Emprint Procedure Planning Application
FDA 510(k) K142048 · Covidien, LLC
510(k) numberK142048
Submission
- Device name
- Emprint Procedure Planning Application
- Applicant
- Covidien, LLC
Mansfield, MA, US - Received
- July 28, 2014
- Decision date
- September 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Emprint Procedure Planning Application cleared by the FDA?
Emprint Procedure Planning Application (K142048) received a 510(k) decision of Substantially Equivalent on September 17, 2014, 51 days after the submission was received.
What is the product code of K142048?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.