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FDA 510(k)

TISSUE OXYGEN MONITOR SYSTEM, MODEL II

K-Number: K890624 · 1989-12-22

ApplicantBaxter Healthcare Corp
Decision Date1989-12-22
Product CodeCCE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TISSUE OXYGEN MONITOR SYSTEM, MODEL II is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-12-22 under 510(k) number K890624. 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 TISSUE OXYGEN MONITOR SYSTEM, MODEL II?

TISSUE OXYGEN MONITOR SYSTEM, MODEL II is a medical device that received FDA 510(k) clearance on 1989-12-22. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K890624.

When did TISSUE OXYGEN MONITOR SYSTEM, MODEL II receive FDA 510(k) clearance?

TISSUE OXYGEN MONITOR SYSTEM, MODEL II received FDA 510(k) clearance on 1989-12-22, under 510(k) number K890624.

Who is the listed applicant for TISSUE OXYGEN MONITOR SYSTEM, MODEL II?

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

What is the FDA product code for TISSUE OXYGEN MONITOR SYSTEM, MODEL II?

The FDA product code for TISSUE OXYGEN MONITOR SYSTEM, MODEL II is CCE.

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Other records listing Baxter Healthcare Corp as applicant

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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.K896311OPTEX BLOOD GAS MONITORING SYSTEMOptex BiomedicalK895149NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SYShiley, 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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