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FDA 510(k)

MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

K-Number: K013564 · 2001-11-21

ApplicantCambridge Heart, Inc.
Decision Date2001-11-21
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS 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 2001-11-21 under 510(k) number K013564. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS?

MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS is a medical device that received FDA 510(k) clearance on 2001-11-21. The listed applicant is Cambridge Heart, Inc.. The 510(k) number is K013564.

When did MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS receive FDA 510(k) clearance?

MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS received FDA 510(k) clearance on 2001-11-21, under 510(k) number K013564.

Who is the listed applicant for MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS?

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 MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS?

The FDA product code for MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS is DPS.

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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 APSK013565CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000K012206ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM

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Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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