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FDA 510(k)

CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308

K-Number: K925484 · 1993-06-22

ApplicantBruel & Kjaer
Decision Date1993-06-22
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 is the device name listed in this FDA 510(k) record. The listed applicant is Bruel & Kjaer. It received FDA 510(k) clearance on 1993-06-22 under 510(k) number K925484. 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 CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308?

CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 is a medical device that received FDA 510(k) clearance on 1993-06-22. The listed applicant is Bruel & Kjaer. The 510(k) number is K925484.

When did CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 receive FDA 510(k) clearance?

CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 received FDA 510(k) clearance on 1993-06-22, under 510(k) number K925484.

Who is the listed applicant for CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308?

The FDA 510(k) record lists Bruel & Kjaer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308?

The FDA product code for CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 is CCK.

Related Clinical Trials

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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Other records listing Bruel & Kjaer 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.

K914295ANESTHETIC GAS MONITOR TYPE 1304, MODIFIEDK905198DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535K911348RIGID ENDOSCOPE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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