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FDA 510(k)

Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR

K-Number: K863159 · 1986-10-06

ApplicantQuinton, Inc.
Decision Date1986-10-06
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1986-10-06 under 510(k) number K863159. 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 Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR?

Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR is a medical device that received FDA 510(k) clearance on 1986-10-06. The listed applicant is Quinton, Inc.. The 510(k) number is K863159.

When did Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR receive FDA 510(k) clearance?

Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR received FDA 510(k) clearance on 1986-10-06, under 510(k) number K863159.

Who is the listed applicant for Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR?

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

What is the FDA product code for Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR?

The FDA product code for Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR is DSI.

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Other records listing Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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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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