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FDA 510(k)

OXYMETER

K-Number: K800631 · 1980-04-02

ApplicantDragerwerk AG
Decision Date1980-04-02
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYMETER is the device name listed in this FDA 510(k) record. The listed applicant is Dragerwerk AG. It received FDA 510(k) clearance on 1980-04-02 under 510(k) number K800631. 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 OXYMETER?

OXYMETER is a medical device that received FDA 510(k) clearance on 1980-04-02. The listed applicant is Dragerwerk AG. The 510(k) number is K800631.

When did OXYMETER receive FDA 510(k) clearance?

OXYMETER received FDA 510(k) clearance on 1980-04-02, under 510(k) number K800631.

Who is the listed applicant for OXYMETER?

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

What is the FDA product code for OXYMETER?

The FDA product code for OXYMETER 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 Dragerwerk AG 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.

K913394INCUBATOR 8000 ICK900752INCUBATOR 8000

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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