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FDA 510(k)

TRANSCUTANEOUS O2/CO2 MONITOR

K-Number: K890517 · 1989-04-14

ApplicantNovametrix Medical Systems, Inc.
Decision Date1989-04-14
Product CodeLKD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS O2/CO2 MONITOR 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 1989-04-14 under 510(k) number K890517. 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 TRANSCUTANEOUS O2/CO2 MONITOR?

TRANSCUTANEOUS O2/CO2 MONITOR is a medical device that received FDA 510(k) clearance on 1989-04-14. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K890517.

When did TRANSCUTANEOUS O2/CO2 MONITOR receive FDA 510(k) clearance?

TRANSCUTANEOUS O2/CO2 MONITOR received FDA 510(k) clearance on 1989-04-14, under 510(k) number K890517.

Who is the listed applicant for TRANSCUTANEOUS O2/CO2 MONITOR?

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 TRANSCUTANEOUS O2/CO2 MONITOR?

The FDA product code for TRANSCUTANEOUS O2/CO2 MONITOR is LKD.

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Other records listing Novametrix Medical Systems, Inc. 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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