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FDA 510(k)

HealthPNX

K-Number: K190362 · 2019-05-06

ApplicantZebra Medical Vision, Ltd.
Decision Date2019-05-06
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HealthPNX is a medical device manufactured by Zebra Medical Vision, Ltd.. It received FDA 510(k) clearance on 2019-05-06 under approval number K190362. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HealthPNX?

HealthPNX is a medical device that received FDA 510(k) clearance on 2019-05-06. It is manufactured by Zebra Medical Vision, Ltd.. The 510(k) number is K190362.

When was HealthPNX approved by the FDA?

HealthPNX received FDA 510(k) clearance on 2019-05-06, under approval number K190362.

What company makes HealthPNX?

HealthPNX is manufactured by Zebra Medical Vision, Ltd..

What is the FDA product code for HealthPNX?

The FDA product code for HealthPNX is QFM.

Other Devices by Zebra Medical Vision, Ltd.

K172983HealthCCS K192320HealthCXR K190424HealthICH K202487HealthJOINT K200905HealthMammo K192901HealthVCF

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Related Devices (Code: QFM)

K192320HealthCXRZebra Medical Vision, Ltd. K183182Critical Care SuiteGe Medical Systems, LLC K183285cmTriageCuremetrix, Inc. K200905HealthMammoZebra Medical Vision, Ltd. K192901HealthVCFZebra Medical Vision, Ltd. K193300AIMI-Triage CXR PTXRadlogics, Inc.

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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