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FDA 510(k)

CS/3(TM) MONITORS*

K-Number: K974792 · 1998-06-02

ApplicantDatex-Engstrom, Inc.
Decision Date1998-06-02
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CS/3(TM) MONITORS* 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 1998-06-02 under 510(k) number K974792. 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(TM) MONITORS*?

CS/3(TM) MONITORS* is a medical device that received FDA 510(k) clearance on 1998-06-02. The listed applicant is Datex-Engstrom, Inc.. The 510(k) number is K974792.

When did CS/3(TM) MONITORS* receive FDA 510(k) clearance?

CS/3(TM) MONITORS* received FDA 510(k) clearance on 1998-06-02, under 510(k) number K974792.

Who is the listed applicant for CS/3(TM) MONITORS*?

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(TM) MONITORS*?

The FDA product code for CS/3(TM) MONITORS* is DSI.

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Other records listing Datex-Engstrom, 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.

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 ACCESSORIESK980384TRIP TONOMETRY CATHETER, 18F

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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.

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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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