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FDA 510(k)

EchoPAC Software Only, EchoPAC Plug-In

K-Number: K200852 · 2020-09-18

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics
Decision Date2020-09-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoPAC Software Only, EchoPAC Plug-In is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2020-09-18 under approval number K200852. 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 EchoPAC Software Only, EchoPAC Plug-In?

EchoPAC Software Only, EchoPAC Plug-In is a medical device that received FDA 510(k) clearance on 2020-09-18. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K200852.

When was EchoPAC Software Only, EchoPAC Plug-In approved by the FDA?

EchoPAC Software Only, EchoPAC Plug-In received FDA 510(k) clearance on 2020-09-18, under approval number K200852.

What company makes EchoPAC Software Only, EchoPAC Plug-In?

EchoPAC Software Only, EchoPAC Plug-In is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.

What is the FDA product code for EchoPAC Software Only, EchoPAC Plug-In?

The FDA product code for EchoPAC Software Only, EchoPAC Plug-In is LLZ.

Other Devices by GE Medical Systems Ultrasound and Primary Care Diagnostics

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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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