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FDA 510(k)

DATEX AIRWAY MONITOR

K-Number: K882885 · 1988-10-19

ApplicantDatex Division Instrumentarium Corp.
Decision Date1988-10-19
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DATEX AIRWAY MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Datex Division Instrumentarium Corp.. It received FDA 510(k) clearance on 1988-10-19 under 510(k) number K882885. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATEX AIRWAY MONITOR?

DATEX AIRWAY MONITOR is a medical device that received FDA 510(k) clearance on 1988-10-19. The listed applicant is Datex Division Instrumentarium Corp.. The 510(k) number is K882885.

When did DATEX AIRWAY MONITOR receive FDA 510(k) clearance?

DATEX AIRWAY MONITOR received FDA 510(k) clearance on 1988-10-19, under 510(k) number K882885.

Who is the listed applicant for DATEX AIRWAY MONITOR?

The FDA 510(k) record lists Datex Division Instrumentarium Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DATEX AIRWAY MONITOR?

The FDA product code for DATEX AIRWAY MONITOR is CCK.

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Other records listing Datex Division Instrumentarium Corp. 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.

K953175AS/3 ESTPR MODULEK961247AS/3 LIGHT MONITORK943458AS/3 AIRWAY MODULEK945234AS/3 MEMORY MODULE, M0MEMK933156DATEX AS/3 PATIENT MONITORK933285DATEX AS/3 TM ANAESTHESIA MONITOR

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Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

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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