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FDA 510(k)

CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000

K-Number: K022149 · 2002-07-16

ApplicantCambridge Heart, Inc.
Decision Date2002-07-16
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 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 2002-07-16 under 510(k) number K022149. 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 CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000?

CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 is a medical device that received FDA 510(k) clearance on 2002-07-16. The listed applicant is Cambridge Heart, Inc.. The 510(k) number is K022149.

When did CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 receive FDA 510(k) clearance?

CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 received FDA 510(k) clearance on 2002-07-16, under 510(k) number K022149.

Who is the listed applicant for CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000?

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 CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000?

The FDA product code for CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 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 SYSTEMK022152HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APSK013564MODIFICATION 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: 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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