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FDA 510(k)

AMERICAN EDWARDS LABS FLEXISCOPE

K-Number: K841607 · 1984-08-18

ApplicantAmerican Edwards Laboratories
Decision Date1984-08-18
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMERICAN EDWARDS LABS FLEXISCOPE 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 1984-08-18 under 510(k) number K841607. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN EDWARDS LABS FLEXISCOPE?

AMERICAN EDWARDS LABS FLEXISCOPE is a medical device that received FDA 510(k) clearance on 1984-08-18. The listed applicant is American Edwards Laboratories. The 510(k) number is K841607.

When did AMERICAN EDWARDS LABS FLEXISCOPE receive FDA 510(k) clearance?

AMERICAN EDWARDS LABS FLEXISCOPE received FDA 510(k) clearance on 1984-08-18, under 510(k) number K841607.

Who is the listed applicant for AMERICAN EDWARDS LABS FLEXISCOPE?

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 AMERICAN EDWARDS LABS FLEXISCOPE?

The FDA product code for AMERICAN EDWARDS LABS FLEXISCOPE is HRX.

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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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