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FDA 510(k)

ARRHYTHMIA MODULE

K-Number: K772360 · 1978-01-12

ApplicantGeneral Electric Co.
Decision Date1978-01-12
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARRHYTHMIA MODULE is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1978-01-12 under 510(k) number K772360. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARRHYTHMIA MODULE?

ARRHYTHMIA MODULE is a medical device that received FDA 510(k) clearance on 1978-01-12. The listed applicant is General Electric Co.. The 510(k) number is K772360.

When did ARRHYTHMIA MODULE receive FDA 510(k) clearance?

ARRHYTHMIA MODULE received FDA 510(k) clearance on 1978-01-12, under 510(k) number K772360.

Who is the listed applicant for ARRHYTHMIA MODULE?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARRHYTHMIA MODULE?

The FDA product code for ARRHYTHMIA MODULE is DSI.

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Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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