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FDA 510(k)

TYPE EXPIRED CO2 9270, CAPNOGRAPH

K-Number: K895001 · 1990-02-22

ApplicantS & W Medico Teknik
Decision Date1990-02-22
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TYPE EXPIRED CO2 9270, CAPNOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is S & W Medico Teknik. It received FDA 510(k) clearance on 1990-02-22 under 510(k) number K895001. 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 TYPE EXPIRED CO2 9270, CAPNOGRAPH?

TYPE EXPIRED CO2 9270, CAPNOGRAPH is a medical device that received FDA 510(k) clearance on 1990-02-22. The listed applicant is S & W Medico Teknik. The 510(k) number is K895001.

When did TYPE EXPIRED CO2 9270, CAPNOGRAPH receive FDA 510(k) clearance?

TYPE EXPIRED CO2 9270, CAPNOGRAPH received FDA 510(k) clearance on 1990-02-22, under 510(k) number K895001.

Who is the listed applicant for TYPE EXPIRED CO2 9270, CAPNOGRAPH?

The FDA 510(k) record lists S & W Medico Teknik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TYPE EXPIRED CO2 9270, CAPNOGRAPH?

The FDA product code for TYPE EXPIRED CO2 9270, CAPNOGRAPH is CCK.

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Other records listing S & W Medico Teknik as applicant

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K9409339267 SPO2 ATHENA MODULEK913013TCPO2 9260 MODULE - SYSTEM ATHENAK915633MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENAK9301349055 IRCA OPTION FOR SYSTEM ATHENA 9050 NTK9234189293/1 INTERFACE MODULEK911611SYSTEM ATHENA, MODIFICATION

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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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