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FDA 510(k)

TRANSCUTANEOUS OXYGEN PERFUSION MONITOR

K-Number: K780458 · 1978-10-10

ApplicantNarco Air-Shields
Decision Date1978-10-10
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS OXYGEN PERFUSION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Narco Air-Shields. It received FDA 510(k) clearance on 1978-10-10 under 510(k) number K780458. 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 PERFUSION MONITOR?

TRANSCUTANEOUS OXYGEN PERFUSION MONITOR is a medical device that received FDA 510(k) clearance on 1978-10-10. The listed applicant is Narco Air-Shields. The 510(k) number is K780458.

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

TRANSCUTANEOUS OXYGEN PERFUSION MONITOR received FDA 510(k) clearance on 1978-10-10, under 510(k) number K780458.

Who is the listed applicant for TRANSCUTANEOUS OXYGEN PERFUSION MONITOR?

The FDA 510(k) record lists Narco Air-Shields as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSCUTANEOUS OXYGEN PERFUSION MONITOR?

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

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Other records listing Narco Air-Shields 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.

K820114SYSTEM V.HEART RATE/RESPIR. RATE MONIT.K810953MODEL 533 PHOTOTHERAPY UNITK810474PROBE COVERK802800NARCO AIR-SHEILDS SYS. 100 MONITOR SYSK802126ISOLETTE INCUBATOR C-100K792592AMBU UNIVERSAL SUCTION PUMP

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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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