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FDA 510(k)

COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE

K-Number: K980756 · 1998-11-05

ApplicantGe Medical Systems Information Technologies
Decision Date1998-11-05
Product CodeLKD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 1998-11-05 under 510(k) number K980756. The device is classified under product code LKD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE?

COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE is a medical device that received FDA 510(k) clearance on 1998-11-05. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K980756.

When did COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE receive FDA 510(k) clearance?

COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE received FDA 510(k) clearance on 1998-11-05, under 510(k) number K980756.

Who is the listed applicant for COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE?

The FDA product code for COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE is LKD.

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Other records listing Ge Medical Systems Information Technologies as applicant

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Related Devices (Code: LKD)

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.

K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AGK131253PERIFLUX 6000Perimed ABK110474PHILIPS INTELLIVUE TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac ANK101690SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLESentec AGK093154TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEMRadiometer Medical ApsK043357TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009Linde Medical Sensors AG

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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