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FDA 510(k)

CARDIAC OUTPUT OPTION 39

K-Number: K943256 · 1994-12-15

ApplicantMedical Data Electronics
Decision Date1994-12-15
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC OUTPUT OPTION 39 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Data Electronics. It received FDA 510(k) clearance on 1994-12-15 under 510(k) number K943256. 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 CARDIAC OUTPUT OPTION 39?

CARDIAC OUTPUT OPTION 39 is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Medical Data Electronics. The 510(k) number is K943256.

When did CARDIAC OUTPUT OPTION 39 receive FDA 510(k) clearance?

CARDIAC OUTPUT OPTION 39 received FDA 510(k) clearance on 1994-12-15, under 510(k) number K943256.

Who is the listed applicant for CARDIAC OUTPUT OPTION 39?

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

What is the FDA product code for CARDIAC OUTPUT OPTION 39?

The FDA product code for CARDIAC OUTPUT OPTION 39 is DXG.

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Other records listing Medical Data Electronics as applicant

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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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