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FDA 510(k)

QUEST EXERCISE STRESS SYSTEM

K-Number: K952417 · 1996-05-22

ApplicantBurdick, Inc.
Decision Date1996-05-22
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUEST EXERCISE STRESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Burdick, Inc.. It received FDA 510(k) clearance on 1996-05-22 under 510(k) number K952417. 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 QUEST EXERCISE STRESS SYSTEM?

QUEST EXERCISE STRESS SYSTEM is a medical device that received FDA 510(k) clearance on 1996-05-22. The listed applicant is Burdick, Inc.. The 510(k) number is K952417.

When did QUEST EXERCISE STRESS SYSTEM receive FDA 510(k) clearance?

QUEST EXERCISE STRESS SYSTEM received FDA 510(k) clearance on 1996-05-22, under 510(k) number K952417.

Who is the listed applicant for QUEST EXERCISE STRESS SYSTEM?

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

What is the FDA product code for QUEST EXERCISE STRESS SYSTEM?

The FDA product code for QUEST EXERCISE STRESS SYSTEM is DSI.

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Other records listing Burdick, 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.

K954267BURDICK 200 PULSE OXIMETERK946281ECLIPSE 4 ELECTROCARDIOGRAPHK945985PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400K943959ECLIPSE 4 ELECTROCARDIOGRAPHK942438ALTAIR 6100 CASSETTE RECORDER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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