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FDA 510(k)

CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM

K-Number: K801224 · 1980-06-26

ApplicantCambridge Instruments, Inc.
Decision Date1980-06-26
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Instruments, Inc.. It received FDA 510(k) clearance on 1980-06-26 under 510(k) number K801224. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM?

CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1980-06-26. The listed applicant is Cambridge Instruments, Inc.. The 510(k) number is K801224.

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

CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1980-06-26, under 510(k) number K801224.

Who is the listed applicant for CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM?

The FDA 510(k) record lists Cambridge Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM?

The FDA product code for CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM is DXK.

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Other records listing Cambridge Instruments, 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.

K811121CENTRAL STATION MONITORING SYSTEMSK811062CAMPBRIDGE COMPUTRACEK8032294-CHANNEL ECG TELEMETRY MON. SYST. #3045K800566CAMBRIDGE VS-550 ELECTROCARDIOGRAPHK792661TREADMILL MODEL 3060K791201SCINTISTRESS SYSTEM

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Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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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