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FDA 510(k)

ERA 3000 PACING SYSTEM ANALYZER

K-Number: K042708 · 2004-10-20

ApplicantBiotronik, Inc.
Decision Date2004-10-20
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ERA 3000 PACING SYSTEM ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2004-10-20 under 510(k) number K042708. 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 ERA 3000 PACING SYSTEM ANALYZER?

ERA 3000 PACING SYSTEM ANALYZER is a medical device that received FDA 510(k) clearance on 2004-10-20. The listed applicant is Biotronik, Inc.. The 510(k) number is K042708.

When did ERA 3000 PACING SYSTEM ANALYZER receive FDA 510(k) clearance?

ERA 3000 PACING SYSTEM ANALYZER received FDA 510(k) clearance on 2004-10-20, under 510(k) number K042708.

Who is the listed applicant for ERA 3000 PACING SYSTEM ANALYZER?

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

What is the FDA product code for ERA 3000 PACING SYSTEM ANALYZER?

The FDA product code for ERA 3000 PACING SYSTEM ANALYZER 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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