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FDA 510(k)

BIOCHEM 9100 MULTIGAS MONITOR

K-Number: K901861 · 1990-07-27

ApplicantBiochem International, Inc.
Decision Date1990-07-27
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIOCHEM 9100 MULTIGAS MONITOR 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 1990-07-27 under 510(k) number K901861. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHEM 9100 MULTIGAS MONITOR?

BIOCHEM 9100 MULTIGAS MONITOR is a medical device that received FDA 510(k) clearance on 1990-07-27. The listed applicant is Biochem International, Inc.. The 510(k) number is K901861.

When did BIOCHEM 9100 MULTIGAS MONITOR receive FDA 510(k) clearance?

BIOCHEM 9100 MULTIGAS MONITOR received FDA 510(k) clearance on 1990-07-27, under 510(k) number K901861.

Who is the listed applicant for BIOCHEM 9100 MULTIGAS MONITOR?

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 BIOCHEM 9100 MULTIGAS MONITOR?

The FDA product code for BIOCHEM 9100 MULTIGAS MONITOR is CCK.

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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: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

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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