FDA 510(k)

HealthJOINT

K-Number: K202487 · 2020-12-04

Decision Date2020-12-04

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HealthJOINT is the device name listed in this FDA 510(k) record. The listed applicant is Zebra Medical Vision, Ltd.. It received FDA 510(k) clearance on 2020-12-04 under 510(k) number K202487. 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 HealthJOINT?

HealthJOINT is a medical device that received FDA 510(k) clearance on 2020-12-04. The listed applicant is Zebra Medical Vision, Ltd.. The 510(k) number is K202487.

When did HealthJOINT receive FDA 510(k) clearance?

HealthJOINT received FDA 510(k) clearance on 2020-12-04, under 510(k) number K202487.

Who is the listed applicant for HealthJOINT?

The FDA 510(k) record lists Zebra Medical Vision, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HealthJOINT?

The FDA product code for HealthJOINT is LLZ.

Other records listing Zebra Medical Vision, Ltd. as applicant

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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.