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FDA 510(k)

EXTERNAL PULSE GENERATOR - EV4542

K-Number: K821791 · 1982-07-06

ApplicantAmerican Pacemaker Corp.
Decision Date1982-07-06
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTERNAL PULSE GENERATOR - EV4542 is the device name listed in this FDA 510(k) record. The listed applicant is American Pacemaker Corp.. It received FDA 510(k) clearance on 1982-07-06 under 510(k) number K821791. 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 EXTERNAL PULSE GENERATOR - EV4542?

EXTERNAL PULSE GENERATOR - EV4542 is a medical device that received FDA 510(k) clearance on 1982-07-06. The listed applicant is American Pacemaker Corp.. The 510(k) number is K821791.

When did EXTERNAL PULSE GENERATOR - EV4542 receive FDA 510(k) clearance?

EXTERNAL PULSE GENERATOR - EV4542 received FDA 510(k) clearance on 1982-07-06, under 510(k) number K821791.

Who is the listed applicant for EXTERNAL PULSE GENERATOR - EV4542?

The FDA 510(k) record lists American Pacemaker Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTERNAL PULSE GENERATOR - EV4542?

The FDA product code for EXTERNAL PULSE GENERATOR - EV4542 is DTE.

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Other records listing American Pacemaker Corp. as applicant

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.

K812830APC IMPLANTABLE PACING LEADK812807APC IMPLANTABLE PACING LEADSK810399APC IMPLANTABEL PACING LEAD, MODEL 3264K810397APC IMPLANTABLE PACING LEAD-FLANGE #3260K810396APC IMPLANTABLE PACING LEAD, TINED #3262K810398APC IMPLANTABLE PACING LEAD, MODEL 3266

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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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