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FDA 510(k)

Halifax Imaging Kit

K-Number: K182880 · 2018-10-31

ApplicantHalifax Biomedical, Inc.
Decision Date2018-10-31
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Halifax Imaging Kit is a medical device manufactured by Halifax Biomedical, Inc.. It received FDA 510(k) clearance on 2018-10-31 under approval number K182880. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Halifax Imaging Kit?

Halifax Imaging Kit is a medical device that received FDA 510(k) clearance on 2018-10-31. It is manufactured by Halifax Biomedical, Inc.. The 510(k) number is K182880.

When was Halifax Imaging Kit approved by the FDA?

Halifax Imaging Kit received FDA 510(k) clearance on 2018-10-31, under approval number K182880.

What company makes Halifax Imaging Kit?

Halifax Imaging Kit is manufactured by Halifax Biomedical, Inc..

What is the FDA product code for Halifax Imaging Kit?

The FDA product code for Halifax Imaging Kit is KPR.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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