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FDA 510(k)

PO-200 BLOOD OXYGEN MONITOR

K-Number: K811836 · 1981-07-27

ApplicantSumitomo Electric Industries, Inc.
Decision Date1981-07-27
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PO-200 BLOOD OXYGEN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Sumitomo Electric Industries, Inc.. It received FDA 510(k) clearance on 1981-07-27 under 510(k) number K811836. 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 PO-200 BLOOD OXYGEN MONITOR?

PO-200 BLOOD OXYGEN MONITOR is a medical device that received FDA 510(k) clearance on 1981-07-27. The listed applicant is Sumitomo Electric Industries, Inc.. The 510(k) number is K811836.

When did PO-200 BLOOD OXYGEN MONITOR receive FDA 510(k) clearance?

PO-200 BLOOD OXYGEN MONITOR received FDA 510(k) clearance on 1981-07-27, under 510(k) number K811836.

Who is the listed applicant for PO-200 BLOOD OXYGEN MONITOR?

The FDA 510(k) record lists Sumitomo Electric Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PO-200 BLOOD OXYGEN MONITOR?

The FDA product code for PO-200 BLOOD OXYGEN MONITOR is KLK.

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Other records listing Sumitomo Electric Industries, Inc. 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.

K852959PO-510 TCPO2 MONITOR

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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