Halifax Imaging Kit
FDA 510(k) K182880 · Halifax Biomedical, Inc.
510(k) numberK182880
Submission
- Device name
- Halifax Imaging Kit
- Applicant
- Halifax Biomedical, Inc.
Mabou, CA - Received
- October 15, 2018
- Decision date
- October 31, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Halifax Imaging Kit cleared by the FDA?
Halifax Imaging Kit (K182880) received a 510(k) decision of Substantially Equivalent on October 31, 2018, 16 days after the submission was received.
What is the product code of K182880?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.