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FDA 510(k)

QUINTON Q2000 ETT MONITORING SYSTEM

K-Number: K820438 · 1982-04-29

ApplicantQuinton, Inc.
Decision Date1982-04-29
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUINTON Q2000 ETT MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1982-04-29 under 510(k) number K820438. 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 QUINTON Q2000 ETT MONITORING SYSTEM?

QUINTON Q2000 ETT MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1982-04-29. The listed applicant is Quinton, Inc.. The 510(k) number is K820438.

When did QUINTON Q2000 ETT MONITORING SYSTEM receive FDA 510(k) clearance?

QUINTON Q2000 ETT MONITORING SYSTEM received FDA 510(k) clearance on 1982-04-29, under 510(k) number K820438.

Who is the listed applicant for QUINTON Q2000 ETT MONITORING SYSTEM?

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 QUINTON Q2000 ETT MONITORING SYSTEM?

The FDA product code for QUINTON Q2000 ETT MONITORING SYSTEM 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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