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FDA 510(k)

CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002

K-Number: K002230 · 2000-08-18

ApplicantCambridge Heart, Inc.
Decision Date2000-08-18
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 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 2000-08-18 under 510(k) number K002230. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002?

CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 is a medical device that received FDA 510(k) clearance on 2000-08-18. The listed applicant is Cambridge Heart, Inc.. The 510(k) number is K002230.

When did CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 receive FDA 510(k) clearance?

CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 received FDA 510(k) clearance on 2000-08-18, under 510(k) number K002230.

Who is the listed applicant for CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002?

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 CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002?

The FDA product code for CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 is DRX.

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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 CH2000K013564MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

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Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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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