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FDA 510(k)

WebPAX

K-Number: K152949 · 2016-08-17

ApplicantHeart Imaging Technologies, LLC
Decision Date2016-08-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WebPAX is a medical device manufactured by Heart Imaging Technologies, LLC. It received FDA 510(k) clearance on 2016-08-17 under approval number K152949. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WebPAX?

WebPAX is a medical device that received FDA 510(k) clearance on 2016-08-17. It is manufactured by Heart Imaging Technologies, LLC. The 510(k) number is K152949.

When was WebPAX approved by the FDA?

WebPAX received FDA 510(k) clearance on 2016-08-17, under approval number K152949.

What company makes WebPAX?

WebPAX is manufactured by Heart Imaging Technologies, LLC.

What is the FDA product code for WebPAX?

The FDA product code for WebPAX is LLZ.

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Official Source

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

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