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FDA 510(k)

CDI(R) 2000 BLOOD GAS MONITOR

K-Number: K884228 · 1989-01-30

ApplicantCardiovascular Devices, Inc.
Decision Date1989-01-30
Product CodeCBZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CDI(R) 2000 BLOOD GAS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Devices, Inc.. It received FDA 510(k) clearance on 1989-01-30 under 510(k) number K884228. 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 CDI(R) 2000 BLOOD GAS MONITOR?

CDI(R) 2000 BLOOD GAS MONITOR is a medical device that received FDA 510(k) clearance on 1989-01-30. The listed applicant is Cardiovascular Devices, Inc.. The 510(k) number is K884228.

When did CDI(R) 2000 BLOOD GAS MONITOR receive FDA 510(k) clearance?

CDI(R) 2000 BLOOD GAS MONITOR received FDA 510(k) clearance on 1989-01-30, under 510(k) number K884228.

Who is the listed applicant for CDI(R) 2000 BLOOD GAS MONITOR?

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

What is the FDA product code for CDI(R) 2000 BLOOD GAS MONITOR?

The FDA product code for CDI(R) 2000 BLOOD GAS MONITOR is CBZ.

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Other records listing Cardiovascular Devices, 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.

K890113THE CDI(R) SYSTEM 400K871221CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300K864703MODIFIED GAS-STAT(TM) MONITORING SYSTEMK843912INTRAVASCULAR BLOOD GAS SYSTEMK840749GAST STAT MONITORING SYSTEMK831225GAS-STAT MONITORING SYSTEM

View all 8 devices →

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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