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FDA 510(k)

FOGARTY FLEXIBLE CALIBRATOR

K-Number: K810894 · 1981-05-15

ApplicantAmerican Edwards Laboratories
Decision Date1981-05-15
Product CodeDWP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOGARTY FLEXIBLE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1981-05-15 under 510(k) number K810894. The device is classified under product code DWP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOGARTY FLEXIBLE CALIBRATOR?

FOGARTY FLEXIBLE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1981-05-15. The listed applicant is American Edwards Laboratories. The 510(k) number is K810894.

When did FOGARTY FLEXIBLE CALIBRATOR receive FDA 510(k) clearance?

FOGARTY FLEXIBLE CALIBRATOR received FDA 510(k) clearance on 1981-05-15, under 510(k) number K810894.

Who is the listed applicant for FOGARTY FLEXIBLE CALIBRATOR?

The FDA 510(k) record lists American Edwards Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOGARTY FLEXIBLE CALIBRATOR?

The FDA product code for FOGARTY FLEXIBLE CALIBRATOR is DWP.

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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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