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FDA 510(k)

RHYTHM VIEW

K-Number: K123295 · 2013-04-24

ApplicantTopera, Inc.
Decision Date2013-04-24
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RHYTHM VIEW is the device name listed in this FDA 510(k) record. The listed applicant is Topera, Inc.. It received FDA 510(k) clearance on 2013-04-24 under 510(k) number K123295. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHYTHM VIEW?

RHYTHM VIEW is a medical device that received FDA 510(k) clearance on 2013-04-24. The listed applicant is Topera, Inc.. The 510(k) number is K123295.

When did RHYTHM VIEW receive FDA 510(k) clearance?

RHYTHM VIEW received FDA 510(k) clearance on 2013-04-24, under 510(k) number K123295.

Who is the listed applicant for RHYTHM VIEW?

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

What is the FDA product code for RHYTHM VIEW?

The FDA product code for RHYTHM VIEW is DQK.

Related Clinical Trials

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.

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Other records listing Topera, Inc. 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.

K133305RHYTHM VIEW WORKSTATIONK130827FIRMAP CATHETERK110878RHYTHMVIEW (TM)

Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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