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FDA 510(k)

TRANSCUTANEOUS 800-OXYGEN MONITORS/801

K-Number: K840993 · 1984-04-24

ApplicantNovametrix Medical Systems, Inc.
Decision Date1984-04-24
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS 800-OXYGEN MONITORS/801 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 1984-04-24 under 510(k) number K840993. 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 800-OXYGEN MONITORS/801?

TRANSCUTANEOUS 800-OXYGEN MONITORS/801 is a medical device that received FDA 510(k) clearance on 1984-04-24. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K840993.

When did TRANSCUTANEOUS 800-OXYGEN MONITORS/801 receive FDA 510(k) clearance?

TRANSCUTANEOUS 800-OXYGEN MONITORS/801 received FDA 510(k) clearance on 1984-04-24, under 510(k) number K840993.

Who is the listed applicant for TRANSCUTANEOUS 800-OXYGEN MONITORS/801?

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 800-OXYGEN MONITORS/801?

The FDA product code for TRANSCUTANEOUS 800-OXYGEN MONITORS/801 is KLK.

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Other records listing Novametrix Medical Systems, Inc. as applicant

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K010451NOVAMETRIX MARQUETTE COMPATIBLE SENSORSK000794MODIFICATION TO MARSPO2, MODEL 2001K993979MARSPO2, MODEL 2001K982499COSMO PLUS WITH NICO, MODEL 8200K964360VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101K963380CO 2 SMO PLUS

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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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