FDA 510(k)

Medtronic Model 5392 External Pulse Generator (EPG)

K号: K162550 · 2016-10-12

决定日期2016-10-12

产品代码DTE

咨询委员会CV

决定Substantially Equivalent

器械摘要

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 2016-10-12 under 510(k) number K162550. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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 2016-10-12. The listed applicant is Medtronic, Inc.. The 510(k) number is K162550.

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 2016-10-12, under 510(k) number K162550.

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.

列明Medtronic, Inc.为申报人的其他记录

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