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FDA 510(k)

ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM

K-Number: K012206 · 2001-10-12

ApplicantCambridge Heart, Inc.
Decision Date2001-10-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING 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 2001-10-12 under 510(k) number K012206. 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 ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM?

ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-10-12. The listed applicant is Cambridge Heart, Inc.. The 510(k) number is K012206.

When did ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM receive FDA 510(k) clearance?

ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM received FDA 510(k) clearance on 2001-10-12, under 510(k) number K012206.

Who is the listed applicant for ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING 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 ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM?

The FDA product code for ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING 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 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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