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FDA 510(k)

MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS

K-Number: K073230 · 2007-12-20

ApplicantBiotronik, Inc.
Decision Date2007-12-20
Product CodeDTA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2007-12-20 under 510(k) number K073230. The device is classified under product code DTA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS?

MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS is a medical device that received FDA 510(k) clearance on 2007-12-20. The listed applicant is Biotronik, Inc.. The 510(k) number is K073230.

When did MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS receive FDA 510(k) clearance?

MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS received FDA 510(k) clearance on 2007-12-20, under 510(k) number K073230.

Who is the listed applicant for MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS?

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 MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS?

The FDA product code for MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS is DTA.

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Related Devices (Code: DTA)

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.

K163008CareLink SmartSync Device Manager - Pacing System AnalyzerMedtronic, Inc.K101982MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180St Jude Medical, CrmdK050884ADAPTER CABLERemington Medical, Inc.K033613MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZERBiotronik, Inc.K022360ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.Biotronik, Inc.K933069MODEL EP-2 CLINICAL STIMULATOREp Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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