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FDA 510(k)

TC-1 CARDIAC OUTPUT COMPUTER

K-Number: K761166 · 1976-12-09

ApplicantWaters Assoc., Inc.
Decision Date1976-12-09
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TC-1 CARDIAC OUTPUT COMPUTER 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 1976-12-09 under 510(k) number K761166. 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 TC-1 CARDIAC OUTPUT COMPUTER?

TC-1 CARDIAC OUTPUT COMPUTER is a medical device that received FDA 510(k) clearance on 1976-12-09. The listed applicant is Waters Assoc., Inc.. The 510(k) number is K761166.

When did TC-1 CARDIAC OUTPUT COMPUTER receive FDA 510(k) clearance?

TC-1 CARDIAC OUTPUT COMPUTER received FDA 510(k) clearance on 1976-12-09, under 510(k) number K761166.

Who is the listed applicant for TC-1 CARDIAC OUTPUT COMPUTER?

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 TC-1 CARDIAC OUTPUT COMPUTER?

The FDA product code for TC-1 CARDIAC OUTPUT COMPUTER is 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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