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FDA 510(k)

HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM

K-Number: K050225 · 2005-04-07

ApplicantCambridge Heart, Inc.
Decision Date2005-04-07
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Heart, Inc.. It received FDA 510(k) clearance on 2005-04-07 under 510(k) number K050225. 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 HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM?

HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 2005-04-07. The listed applicant is Cambridge Heart, Inc.. The 510(k) number is K050225.

When did HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 2005-04-07, under 510(k) number K050225.

Who is the listed applicant for HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM?

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

What is the FDA product code for HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM?

The FDA product code for HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM is DQK.

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Other records listing Cambridge Heart, 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.

K100362CAMBRIDGE HEART OEMK022152HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APSK022149CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000K013564MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APSK013565CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000K012206ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM

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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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