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FDA 510(k)

IMS-2000S STRESS MONITOR

K-Number: K871659 · 1987-05-28

ApplicantIntegrated Medical Systems, Inc.
Decision Date1987-05-28
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMS-2000S STRESS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Medical Systems, Inc.. It received FDA 510(k) clearance on 1987-05-28 under 510(k) number K871659. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMS-2000S STRESS MONITOR?

IMS-2000S STRESS MONITOR is a medical device that received FDA 510(k) clearance on 1987-05-28. The listed applicant is Integrated Medical Systems, Inc.. The 510(k) number is K871659.

When did IMS-2000S STRESS MONITOR receive FDA 510(k) clearance?

IMS-2000S STRESS MONITOR received FDA 510(k) clearance on 1987-05-28, under 510(k) number K871659.

Who is the listed applicant for IMS-2000S STRESS MONITOR?

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

What is the FDA product code for IMS-2000S STRESS MONITOR?

The FDA product code for IMS-2000S STRESS MONITOR is DXG.

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Other records listing Integrated Medical Systems, 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.

K082256LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITEK902682STICK-GARD STERILE CAPK895414MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEMK870934IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM

Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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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