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FDA 510(k)

CS/3 COMPACT AIRWAY MODULE, M-COVX

K-Number: K982091 · 1998-12-22

ApplicantDatex-Engstrom, Inc.
Decision Date1998-12-22
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CS/3 COMPACT AIRWAY MODULE, M-COVX 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 1998-12-22 under 510(k) number K982091. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS/3 COMPACT AIRWAY MODULE, M-COVX?

CS/3 COMPACT AIRWAY MODULE, M-COVX is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Datex-Engstrom, Inc.. The 510(k) number is K982091.

When did CS/3 COMPACT AIRWAY MODULE, M-COVX receive FDA 510(k) clearance?

CS/3 COMPACT AIRWAY MODULE, M-COVX received FDA 510(k) clearance on 1998-12-22, under 510(k) number K982091.

Who is the listed applicant for CS/3 COMPACT AIRWAY MODULE, M-COVX?

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 COMPACT AIRWAY MODULE, M-COVX?

The FDA product code for CS/3 COMPACT AIRWAY MODULE, M-COVX is MHX.

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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, 16FK981378DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1K973985AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)K980362MRI COMPATIBLE MONITOR AND ACCESSORIESK974792CS/3(TM) MONITORS*K980384TRIP TONOMETRY CATHETER, 18F

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Related Devices (Code: MHX)

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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