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FDA 510(k)

PDS THERMAL DILUTION CARDIAC MODULE(OUT)

K-Number: K802316 · 1980-11-26

ApplicantGeneral Electric Co.
Decision Date1980-11-26
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PDS THERMAL DILUTION CARDIAC MODULE(OUT) is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1980-11-26 under 510(k) number K802316. 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 PDS THERMAL DILUTION CARDIAC MODULE(OUT)?

PDS THERMAL DILUTION CARDIAC MODULE(OUT) is a medical device that received FDA 510(k) clearance on 1980-11-26. The listed applicant is General Electric Co.. The 510(k) number is K802316.

When did PDS THERMAL DILUTION CARDIAC MODULE(OUT) receive FDA 510(k) clearance?

PDS THERMAL DILUTION CARDIAC MODULE(OUT) received FDA 510(k) clearance on 1980-11-26, under 510(k) number K802316.

Who is the listed applicant for PDS THERMAL DILUTION CARDIAC MODULE(OUT)?

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

What is the FDA product code for PDS THERMAL DILUTION CARDIAC MODULE(OUT)?

The FDA product code for PDS THERMAL DILUTION CARDIAC MODULE(OUT) is DXG.

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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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