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FDA 510(k)

595 ARRHYTHMIA MONITORING SYSTEM

K-Number: K852250 · 1986-05-02

ApplicantBurdick Corp.
Decision Date1986-05-02
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

595 ARRHYTHMIA MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K852250. 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 595 ARRHYTHMIA MONITORING SYSTEM?

595 ARRHYTHMIA MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Burdick Corp.. The 510(k) number is K852250.

When did 595 ARRHYTHMIA MONITORING SYSTEM receive FDA 510(k) clearance?

595 ARRHYTHMIA MONITORING SYSTEM received FDA 510(k) clearance on 1986-05-02, under 510(k) number K852250.

Who is the listed applicant for 595 ARRHYTHMIA MONITORING SYSTEM?

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

What is the FDA product code for 595 ARRHYTHMIA MONITORING SYSTEM?

The FDA product code for 595 ARRHYTHMIA MONITORING SYSTEM is DSI.

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Other records listing Burdick Corp. 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.

K942565ALTAIR-DISC RECORDERK941351BURDICK PRO2 OXIMETERK904032ELITE II ELECTROCARDIOGRAPHK903565E560 ELECTROCARDIOGRAPHK900729NEOSERV 824K885085ERGOMED 840/ERGOMED 840L

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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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