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FDA 510(k)

BIOCHEM 9090 CAPNOGRAPH/SAO2

K-Number: K873856 · 1987-12-17

ApplicantBiochem International, Inc.
Decision Date1987-12-17
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIOCHEM 9090 CAPNOGRAPH/SAO2 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 1987-12-17 under 510(k) number K873856. 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 9090 CAPNOGRAPH/SAO2?

BIOCHEM 9090 CAPNOGRAPH/SAO2 is a medical device that received FDA 510(k) clearance on 1987-12-17. The listed applicant is Biochem International, Inc.. The 510(k) number is K873856.

When did BIOCHEM 9090 CAPNOGRAPH/SAO2 receive FDA 510(k) clearance?

BIOCHEM 9090 CAPNOGRAPH/SAO2 received FDA 510(k) clearance on 1987-12-17, under 510(k) number K873856.

Who is the listed applicant for BIOCHEM 9090 CAPNOGRAPH/SAO2?

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 9090 CAPNOGRAPH/SAO2?

The FDA product code for BIOCHEM 9090 CAPNOGRAPH/SAO2 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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