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FDA 510(k)

HealthICH

K-Number: K190424 · 2019-06-13

Decision Date2019-06-13
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HealthICH is a medical device manufactured by Zebra Medical Vision, Ltd.. It received FDA 510(k) clearance on 2019-06-13 under approval number K190424. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HealthICH?

HealthICH is a medical device that received FDA 510(k) clearance on 2019-06-13. It is manufactured by Zebra Medical Vision, Ltd.. The 510(k) number is K190424.

When was HealthICH approved by the FDA?

HealthICH received FDA 510(k) clearance on 2019-06-13, under approval number K190424.

What company makes HealthICH?

HealthICH is manufactured by Zebra Medical Vision, Ltd..

What is the FDA product code for HealthICH?

The FDA product code for HealthICH is QAS.

Other Devices by Zebra Medical Vision, Ltd.

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Related Devices (Code: QAS)

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.