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FDA 510(k)

515A NEO-TRAK NEONATAL MONITOR

K-Number: K861861 · 1986-07-10

ApplicantGe Medical Systems Information Technologies
Decision Date1986-07-10
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

515A NEO-TRAK NEONATAL MONITOR 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 1986-07-10 under 510(k) number K861861. 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 515A NEO-TRAK NEONATAL MONITOR?

515A NEO-TRAK NEONATAL MONITOR is a medical device that received FDA 510(k) clearance on 1986-07-10. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K861861.

When did 515A NEO-TRAK NEONATAL MONITOR receive FDA 510(k) clearance?

515A NEO-TRAK NEONATAL MONITOR received FDA 510(k) clearance on 1986-07-10, under 510(k) number K861861.

Who is the listed applicant for 515A NEO-TRAK NEONATAL MONITOR?

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 515A NEO-TRAK NEONATAL MONITOR?

The FDA product code for 515A NEO-TRAK NEONATAL MONITOR is KLK.

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Other records listing Ge Medical Systems Information Technologies 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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