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FDA 510(k)

SENSOMAT

K-Number: K803014 · 1980-12-22

ApplicantBiochem International, Inc.
Decision Date1980-12-22
Product CodeCBZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SENSOMAT 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 1980-12-22 under 510(k) number K803014. The device is classified under product code CBZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSOMAT?

SENSOMAT is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Biochem International, Inc.. The 510(k) number is K803014.

When did SENSOMAT receive FDA 510(k) clearance?

SENSOMAT received FDA 510(k) clearance on 1980-12-22, under 510(k) number K803014.

Who is the listed applicant for SENSOMAT?

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 SENSOMAT?

The FDA product code for SENSOMAT is CBZ.

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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 OXIMETERK910381BIOCHEM TEMPERATURE/ FIO2 MODULEK911351BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP

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Related Devices (Code: CBZ)

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.

K020967TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEMTerumo Cardiovascular Systems Corp.K970906PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSORDiametrics Medical, Ltd.K931112MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODIPuritan Bennett Corp.K920061HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEMAbbott LaboratoriesK912030CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED3M CompanyK912428PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENTPuritan Bennett Corp.

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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