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FDA 510(k)

CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER

K-Number: K893392 · 1989-06-20

ApplicantBaxter Healthcare Corp
Decision Date1989-06-20
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER 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 1989-06-20 under 510(k) number K893392. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER?

CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER is a medical device that received FDA 510(k) clearance on 1989-06-20. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K893392.

When did CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER receive FDA 510(k) clearance?

CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER received FDA 510(k) clearance on 1989-06-20, under 510(k) number K893392.

Who is the listed applicant for CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER?

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 CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER?

The FDA product code for CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER is DXG.

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Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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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