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FDA 510(k)

CS/3 ARRHYTHMIA WORKSTATION

K-Number: K974747 · 1998-04-23

ApplicantDatex-Engstrom, Inc.
Decision Date1998-04-23
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CS/3 ARRHYTHMIA WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Engstrom, Inc.. It received FDA 510(k) clearance on 1998-04-23 under 510(k) number K974747. 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 CS/3 ARRHYTHMIA WORKSTATION?

CS/3 ARRHYTHMIA WORKSTATION is a medical device that received FDA 510(k) clearance on 1998-04-23. The listed applicant is Datex-Engstrom, Inc.. The 510(k) number is K974747.

When did CS/3 ARRHYTHMIA WORKSTATION receive FDA 510(k) clearance?

CS/3 ARRHYTHMIA WORKSTATION received FDA 510(k) clearance on 1998-04-23, under 510(k) number K974747.

Who is the listed applicant for CS/3 ARRHYTHMIA WORKSTATION?

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

What is the FDA product code for CS/3 ARRHYTHMIA WORKSTATION?

The FDA product code for CS/3 ARRHYTHMIA WORKSTATION is DSI.

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Other records listing Datex-Engstrom, Inc. as applicant

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K983366TRIP TONOMETRY CATHETER, 16FK982091CS/3 COMPACT AIRWAY MODULE, M-COVXK981378DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1K973985AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)K980362MRI COMPATIBLE MONITOR AND ACCESSORIESK974792CS/3(TM) MONITORS*

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Related Devices (Code: DSI)

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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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