FDA 510(k)

Medtronic Model 5392 External Pulse Generator (EPG)

K-Number: K190825 · 2019-04-30

Decision Date2019-04-30

Product CodeDTE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Medtronic Model 5392 External Pulse Generator (EPG) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2019-04-30 under 510(k) number K190825. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medtronic Model 5392 External Pulse Generator (EPG)?

Medtronic Model 5392 External Pulse Generator (EPG) is a medical device that received FDA 510(k) clearance on 2019-04-30. The listed applicant is Medtronic, Inc.. The 510(k) number is K190825.

When did Medtronic Model 5392 External Pulse Generator (EPG) receive FDA 510(k) clearance?

Medtronic Model 5392 External Pulse Generator (EPG) received FDA 510(k) clearance on 2019-04-30, under 510(k) number K190825.

Who is the listed applicant for Medtronic Model 5392 External Pulse Generator (EPG)?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medtronic Model 5392 External Pulse Generator (EPG)?

The FDA product code for Medtronic Model 5392 External Pulse Generator (EPG) is DTE.

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Related Devices (Code: DTE)

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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.