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FDA 510(k)

TRANSCUTANEOUS OXYGEN MONITOR OPTION

K-Number: K831744 · 1983-07-19

ApplicantGe Medical Systems Information Technologies
Decision Date1983-07-19
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS OXYGEN MONITOR OPTION 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 1983-07-19 under 510(k) number K831744. 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 TRANSCUTANEOUS OXYGEN MONITOR OPTION?

TRANSCUTANEOUS OXYGEN MONITOR OPTION is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K831744.

When did TRANSCUTANEOUS OXYGEN MONITOR OPTION receive FDA 510(k) clearance?

TRANSCUTANEOUS OXYGEN MONITOR OPTION received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831744.

Who is the listed applicant for TRANSCUTANEOUS OXYGEN MONITOR OPTION?

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 TRANSCUTANEOUS OXYGEN MONITOR OPTION?

The FDA product code for TRANSCUTANEOUS OXYGEN MONITOR OPTION is KLK.

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Other records listing Ge Medical Systems Information Technologies 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.

K120770QT GUARD PLUS ANALYSIS SYSTEMK102426CARESCAPE MODEL V100 VITAL SIGNS MONITORK09236912SL ECG ANALYSIS PROGRAMK093141MARS HOLTER ANALYSIS WORKSTATIONK092027CARESCAPE MONITOR B850K090702MODIFICATION TO DASH 2500 PATIENT MONITOR

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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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