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FDA 510(k)

OPTEX BLOOD GAS MONITORING SYSTEM

K-Number: K896311 · 1990-01-03

ApplicantOptex Biomedical
Decision Date1990-01-03
Product CodeCCE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OPTEX BLOOD GAS MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Optex Biomedical. It received FDA 510(k) clearance on 1990-01-03 under 510(k) number K896311. 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 OPTEX BLOOD GAS MONITORING SYSTEM?

OPTEX BLOOD GAS MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1990-01-03. The listed applicant is Optex Biomedical. The 510(k) number is K896311.

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

OPTEX BLOOD GAS MONITORING SYSTEM received FDA 510(k) clearance on 1990-01-03, under 510(k) number K896311.

Who is the listed applicant for OPTEX BLOOD GAS MONITORING SYSTEM?

The FDA 510(k) record lists Optex Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTEX BLOOD GAS MONITORING SYSTEM?

The FDA product code for OPTEX BLOOD GAS MONITORING SYSTEM is CCE.

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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.K890624TISSUE OXYGEN MONITOR SYSTEM, MODEL IIBaxter Healthcare CorpK895150CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORINGShiley, 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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