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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 the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2020-09-18 under 510(k) 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. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K200852.

When did EchoPAC Software Only, EchoPAC Plug-In receive FDA 510(k) clearance?

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

Who is the listed applicant for EchoPAC Software Only, EchoPAC Plug-In?

The FDA 510(k) record lists GE Medical Systems Ultrasound and Primary Care Diagnostics as the applicant. This does not by itself establish the device manufacturer.

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.

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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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