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FDA 510(k)

MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL

K-Number: K853669 · 1986-03-31

ApplicantHewlett-Packard Co.
Decision Date1986-03-31
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard Co.. It received FDA 510(k) clearance on 1986-03-31 under 510(k) number K853669. 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 MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL?

MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL is a medical device that received FDA 510(k) clearance on 1986-03-31. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K853669.

When did MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL receive FDA 510(k) clearance?

MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL received FDA 510(k) clearance on 1986-03-31, under 510(k) number K853669.

Who is the listed applicant for MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL?

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

What is the FDA product code for MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL?

The FDA product code for MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL is DSI.

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Other records listing Hewlett-Packard Co. as applicant

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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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