Comfort Cover
FDA 510(k) K161920 · Precision Dynamics Corporation
510(k) numberK161920
Submission
- Device name
- Comfort Cover
- Applicant
- Precision Dynamics Corporation
Valencia, CA, US - Received
- July 13, 2016
- Decision date
- July 15, 2016
- 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 Comfort Cover cleared by the FDA?
Comfort Cover (K161920) received a 510(k) decision of Substantially Equivalent on July 15, 2016, 2 days after the submission was received.
What is the product code of K161920?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.