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FDA 510(k)

MONITOR, SENSOMATIII OXYGEN

K-Number: K781910 · 1978-12-26

ApplicantBiochem International, Inc.
Decision Date1978-12-26
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MONITOR, SENSOMATIII OXYGEN is the device name listed in this FDA 510(k) record. The listed applicant is Biochem International, Inc.. It received FDA 510(k) clearance on 1978-12-26 under 510(k) number K781910. 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 MONITOR, SENSOMATIII OXYGEN?

MONITOR, SENSOMATIII OXYGEN is a medical device that received FDA 510(k) clearance on 1978-12-26. The listed applicant is Biochem International, Inc.. The 510(k) number is K781910.

When did MONITOR, SENSOMATIII OXYGEN receive FDA 510(k) clearance?

MONITOR, SENSOMATIII OXYGEN received FDA 510(k) clearance on 1978-12-26, under 510(k) number K781910.

Who is the listed applicant for MONITOR, SENSOMATIII OXYGEN?

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

What is the FDA product code for MONITOR, SENSOMATIII OXYGEN?

The FDA product code for MONITOR, SENSOMATIII OXYGEN is KLK.

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Other records listing Biochem International, 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.

K920083BIOCHEM MODEL 3302 NEWOX2 OXIMETERK9323898100 ANESTHETIC AGENT MONITORK921388BIOCHEM 9100 MULTIGAS MONITOR IBP MODULEK920082BIOCHEM MODEL 3301 NEWOX1 OXIMETERK911351BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBPK910381BIOCHEM TEMPERATURE/ FIO2 MODULE

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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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