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FDA 510(k)

INTRAVASCULAR BLOOD GAS SYSTEM

K-Number: K843912 · 1985-01-10

ApplicantCardiovascular Devices, Inc.
Decision Date1985-01-10
Product CodeCCE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INTRAVASCULAR BLOOD GAS SYSTEM 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 1985-01-10 under 510(k) number K843912. The device is classified under product code CCE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAVASCULAR BLOOD GAS SYSTEM?

INTRAVASCULAR BLOOD GAS SYSTEM is a medical device that received FDA 510(k) clearance on 1985-01-10. The listed applicant is Cardiovascular Devices, Inc.. The 510(k) number is K843912.

When did INTRAVASCULAR BLOOD GAS SYSTEM receive FDA 510(k) clearance?

INTRAVASCULAR BLOOD GAS SYSTEM received FDA 510(k) clearance on 1985-01-10, under 510(k) number K843912.

Who is the listed applicant for INTRAVASCULAR BLOOD GAS SYSTEM?

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 INTRAVASCULAR BLOOD GAS SYSTEM?

The FDA product code for INTRAVASCULAR BLOOD GAS SYSTEM is CCE.

Related Clinical Trials

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.

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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 400K884228CDI(R) 2000 BLOOD GAS MONITORK871221CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300K864703MODIFIED GAS-STAT(TM) MONITORING SYSTEMK840749GAST STAT MONITORING SYSTEMK831225GAS-STAT MONITORING SYSTEM

View all 8 devices →

Related Devices (Code: CCE)

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.

K935778VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEMVia Medical Corp.K912145SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIAS & W Medico TeknikK910453TOPS NEEDLE TIP PROBE & PVC TIP PROBEBaxter Healthcare CorpK905397PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEMPuritan Bennett Corp.K896311OPTEX BLOOD GAS MONITORING SYSTEMOptex BiomedicalK890624TISSUE OXYGEN MONITOR SYSTEM, MODEL IIBaxter Healthcare 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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