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FDA 510(k)

TCO2M MODEL 818

K-Number: K791152 · 1979-08-03

ApplicantNovametrix Medical Systems, Inc.
Decision Date1979-08-03
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TCO2M MODEL 818 is the device name listed in this FDA 510(k) record. The listed applicant is Novametrix Medical Systems, Inc.. It received FDA 510(k) clearance on 1979-08-03 under 510(k) number K791152. The device is classified under product code KLK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TCO2M MODEL 818?

TCO2M MODEL 818 is a medical device that received FDA 510(k) clearance on 1979-08-03. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K791152.

When did TCO2M MODEL 818 receive FDA 510(k) clearance?

TCO2M MODEL 818 received FDA 510(k) clearance on 1979-08-03, under 510(k) number K791152.

Who is the listed applicant for TCO2M MODEL 818?

The FDA 510(k) record lists Novametrix Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TCO2M MODEL 818?

The FDA product code for TCO2M MODEL 818 is KLK.

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Other records listing Novametrix Medical Systems, Inc. as applicant

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Related Devices (Code: KLK)

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.

K003943MICROGAS 7650 TRANSCUTANEOUS MONITORLinde Medical Sensors AGK991644MICROGAS 7650 TRANSCUTANEOUS MONITORLinde Medical Sensors AGK980287SIEMENS SC9000/SC9015 TCP02/C02 MODULESiemens Medical Solutions USA, Inc.K924709SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETEAir-Shields, Inc.K924679OXYCARE(TM) OXYGEN CONTROLLER/MONITORAir-Shields Vickers, Inc.K925910HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULEHewlett-Packard Co.

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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