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FDA 510(k)

SERVOMED OXYMONITO SMK 363

K-Number: K842497 · 1984-10-04

ApplicantLitton Datamedix
Decision Date1984-10-04
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SERVOMED OXYMONITO SMK 363 is the device name listed in this FDA 510(k) record. The listed applicant is Litton Datamedix. It received FDA 510(k) clearance on 1984-10-04 under 510(k) number K842497. 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 SERVOMED OXYMONITO SMK 363?

SERVOMED OXYMONITO SMK 363 is a medical device that received FDA 510(k) clearance on 1984-10-04. The listed applicant is Litton Datamedix. The 510(k) number is K842497.

When did SERVOMED OXYMONITO SMK 363 receive FDA 510(k) clearance?

SERVOMED OXYMONITO SMK 363 received FDA 510(k) clearance on 1984-10-04, under 510(k) number K842497.

Who is the listed applicant for SERVOMED OXYMONITO SMK 363?

The FDA 510(k) record lists Litton Datamedix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERVOMED OXYMONITO SMK 363?

The FDA product code for SERVOMED OXYMONITO SMK 363 is KLK.

Related Clinical Trials

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.

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Other records listing Litton Datamedix 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.

K853599LITTON DATAMEDIX BLOOD PRESSURE MONITOR NIK850290ULTRASOUND GELK842312SERVOCARD SCP-840K842235SERVOCARD DEFIBRILLATOR SCP-851

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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