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FDA 510(k)

CH 2000 CARDIAC DIAGNOSTIC SYSTEM

K-Number: K010756 · 2001-04-12

ApplicantCambridge Heart, Inc.
Decision Date2001-04-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CH 2000 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 2001-04-12 under 510(k) number K010756. 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 CH 2000 CARDIAC DIAGNOSTIC SYSTEM?

CH 2000 CARDIAC DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 2001-04-12. The listed applicant is Cambridge Heart, Inc.. The 510(k) number is K010756.

When did CH 2000 CARDIAC DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

CH 2000 CARDIAC DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 2001-04-12, under 510(k) number K010756.

Who is the listed applicant for CH 2000 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 CH 2000 CARDIAC DIAGNOSTIC SYSTEM?

The FDA product code for CH 2000 CARDIAC DIAGNOSTIC SYSTEM is DQK.

Related Clinical Trials

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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 OEMK050225HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEMK022149CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000K022152HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APSK013564MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APSK013565CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000

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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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