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FDA 510(k)

TX-2 THERMAL DILUTION CARDIAC OUTPUT

K-Number: K834408 · 1984-08-23

ApplicantWaters Instruments, Inc.
Decision Date1984-08-23
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TX-2 THERMAL DILUTION CARDIAC OUTPUT is the device name listed in this FDA 510(k) record. The listed applicant is Waters Instruments, Inc.. It received FDA 510(k) clearance on 1984-08-23 under 510(k) number K834408. 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 TX-2 THERMAL DILUTION CARDIAC OUTPUT?

TX-2 THERMAL DILUTION CARDIAC OUTPUT is a medical device that received FDA 510(k) clearance on 1984-08-23. The listed applicant is Waters Instruments, Inc.. The 510(k) number is K834408.

When did TX-2 THERMAL DILUTION CARDIAC OUTPUT receive FDA 510(k) clearance?

TX-2 THERMAL DILUTION CARDIAC OUTPUT received FDA 510(k) clearance on 1984-08-23, under 510(k) number K834408.

Who is the listed applicant for TX-2 THERMAL DILUTION CARDIAC OUTPUT?

The FDA 510(k) record lists Waters Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TX-2 THERMAL DILUTION CARDIAC OUTPUT?

The FDA product code for TX-2 THERMAL DILUTION CARDIAC OUTPUT is DXG.

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Other records listing Waters Instruments, Inc. as applicant

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Related Devices (Code: DXG)

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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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