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FDA 510(k)

MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)

K-Number: K132924 · 2013-10-31

ApplicantMedtronic, Inc.
Decision Date2013-10-31
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC 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 2013-10-31 under 510(k) number K132924. 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 EXTERNAL PULSE GENERATOR (EPG)?

MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) is a medical device that received FDA 510(k) clearance on 2013-10-31. The listed applicant is Medtronic, Inc.. The 510(k) number is K132924.

When did MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) receive FDA 510(k) clearance?

MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) received FDA 510(k) clearance on 2013-10-31, under 510(k) number K132924.

Who is the listed applicant for MEDTRONIC 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 EXTERNAL PULSE GENERATOR (EPG)?

The FDA product code for MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) is DTE.

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Related Devices (Code: DTE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241781Solo Pace ControlSolo Pace, Inc.K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K201011Medtronic Model 5392 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.K181973Medtronic 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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