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FDA 510(k)

TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300

K-Number: K802978 · 1981-02-02

ApplicantBrattle Instrument Corp.
Decision Date1981-02-02
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 is the device name listed in this FDA 510(k) record. The listed applicant is Brattle Instrument Corp.. It received FDA 510(k) clearance on 1981-02-02 under 510(k) number K802978. 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 BLOOD OXYGEN MONITOR #300?

TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 is a medical device that received FDA 510(k) clearance on 1981-02-02. The listed applicant is Brattle Instrument Corp.. The 510(k) number is K802978.

When did TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 receive FDA 510(k) clearance?

TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 received FDA 510(k) clearance on 1981-02-02, under 510(k) number K802978.

Who is the listed applicant for TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300?

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

What is the FDA product code for TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300?

The FDA product code for TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 is KLK.

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Other records listing Brattle Instrument Corp. 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.

K810588SYNCHRONIZER #208K781681PHIPIOLOGICAL SYNCHRONIZER PART#205K770692MONITOR, FETAL, NO. L04-1100K770296FETAL MONITOR, PART #101-11009K770295ABDOMINAL ECG PROCESSOR FOR FETAL MONI.K770297FETAL MONITOR, PART #100-11009

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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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