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FDA 510(k)

CARDIAC COMPUTERS, CO-10 & CO-10R

K-Number: K781805 · 1979-01-29

ApplicantWaters Assoc., Inc.
Decision Date1979-01-29
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC COMPUTERS, CO-10 & CO-10R is the device name listed in this FDA 510(k) record. The listed applicant is Waters Assoc., Inc.. It received FDA 510(k) clearance on 1979-01-29 under 510(k) number K781805. 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 COMPUTERS, CO-10 & CO-10R?

CARDIAC COMPUTERS, CO-10 & CO-10R is a medical device that received FDA 510(k) clearance on 1979-01-29. The listed applicant is Waters Assoc., Inc.. The 510(k) number is K781805.

When did CARDIAC COMPUTERS, CO-10 & CO-10R receive FDA 510(k) clearance?

CARDIAC COMPUTERS, CO-10 & CO-10R received FDA 510(k) clearance on 1979-01-29, under 510(k) number K781805.

Who is the listed applicant for CARDIAC COMPUTERS, CO-10 & CO-10R?

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

What is the FDA product code for CARDIAC COMPUTERS, CO-10 & CO-10R?

The FDA product code for CARDIAC COMPUTERS, CO-10 & CO-10R is DXG.

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Other records listing Waters Assoc., Inc. as applicant

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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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