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FDA 510(k)

OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER

K-Number: K895780 · 1989-11-29

ApplicantDatex Division Instrumentarium Corp.
Decision Date1989-11-29
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER 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 1989-11-29 under 510(k) number K895780. 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 OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER?

OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 1989-11-29. The listed applicant is Datex Division Instrumentarium Corp.. The 510(k) number is K895780.

When did OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER receive FDA 510(k) clearance?

OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER received FDA 510(k) clearance on 1989-11-29, under 510(k) number K895780.

Who is the listed applicant for OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER?

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 OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER?

The FDA product code for OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER is CCK.

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Other records listing Datex Division Instrumentarium Corp. as applicant

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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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