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FDA 510(k)

REUSABLE FOGARTY FLEXIBLE CALIBRATOR

K-Number: K822687 · 1982-10-04

ApplicantAmerican Edwards Laboratories
Decision Date1982-10-04
Product CodeDWP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REUSABLE 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 1982-10-04 under 510(k) number K822687. 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 REUSABLE FOGARTY FLEXIBLE CALIBRATOR?

REUSABLE FOGARTY FLEXIBLE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1982-10-04. The listed applicant is American Edwards Laboratories. The 510(k) number is K822687.

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

REUSABLE FOGARTY FLEXIBLE CALIBRATOR received FDA 510(k) clearance on 1982-10-04, under 510(k) number K822687.

Who is the listed applicant for REUSABLE 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 REUSABLE FOGARTY FLEXIBLE CALIBRATOR?

The FDA product code for REUSABLE 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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