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FDA 510(k)

CARDIOSERVER

K-Number: K052883 · 2005-11-01

ApplicantDatrix
Decision Date2005-11-01
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSERVER is the device name listed in this FDA 510(k) record. The listed applicant is Datrix. It received FDA 510(k) clearance on 2005-11-01 under 510(k) number K052883. 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 CARDIOSERVER?

CARDIOSERVER is a medical device that received FDA 510(k) clearance on 2005-11-01. The listed applicant is Datrix. The 510(k) number is K052883.

When did CARDIOSERVER receive FDA 510(k) clearance?

CARDIOSERVER received FDA 510(k) clearance on 2005-11-01, under 510(k) number K052883.

Who is the listed applicant for CARDIOSERVER?

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

What is the FDA product code for CARDIOSERVER?

The FDA product code for CARDIOSERVER is DQK.

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Other records listing Datrix 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.

K053083DATRIX CARDIO WIFI ELECTROCARDIOGRAPHK031074DIGITAL AMBULATORY ECG (HOLTER) RECORDERK982975DIGITAL ECG HOLTER RECORDER, MODEL DR512K921068GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300

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

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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