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FDA 510(k)

PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM

K-Number: K852968 · 1985-11-14

ApplicantPersonal Computers For Medicine, Inc.
Decision Date1985-11-14
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Personal Computers For Medicine, Inc.. It received FDA 510(k) clearance on 1985-11-14 under 510(k) number K852968. 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 PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM?

PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1985-11-14. The listed applicant is Personal Computers For Medicine, Inc.. The 510(k) number is K852968.

When did PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM receive FDA 510(k) clearance?

PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM received FDA 510(k) clearance on 1985-11-14, under 510(k) number K852968.

Who is the listed applicant for PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM?

The FDA 510(k) record lists Personal Computers For Medicine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM?

The FDA product code for PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM is DSI.

Related Clinical Trials

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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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