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FDA 510(k)

Medtronic Model 5392 External Pulse Generator (EPG)

K-Number: K181973 · 2018-08-21

ApplicantMedtronic, Inc.
Decision Date2018-08-21
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medtronic Model 5392 External Pulse Generator (EPG) is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2018-08-21 under approval number K181973. 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 2018-08-21. It is manufactured by Medtronic, Inc.. The 510(k) number is K181973.

When was Medtronic Model 5392 External Pulse Generator (EPG) approved by the FDA?

Medtronic Model 5392 External Pulse Generator (EPG) received FDA 510(k) clearance on 2018-08-21, under approval number K181973.

What company makes Medtronic Model 5392 External Pulse Generator (EPG)?

Medtronic Model 5392 External Pulse Generator (EPG) is manufactured by Medtronic, Inc..

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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Other Devices by Medtronic, Inc.

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Related Devices (Code: DTE)

K162054Medtronic Temporary External Pacemaker 53401Medtronic, Inc. K162550Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. K180873Medtronic Model 53401 External Pulse Generator (EPG)Medtronic, Inc. K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, 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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