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FDA 510(k)

AMERICAN EDWARDS LABORATORIES FLEXISCOPE

K-Number: K852759 · 1985-08-22

ApplicantAmerican Edwards Laboratories
Decision Date1985-08-22
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMERICAN EDWARDS LABORATORIES 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 1985-08-22 under 510(k) number K852759. 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 LABORATORIES FLEXISCOPE?

AMERICAN EDWARDS LABORATORIES FLEXISCOPE is a medical device that received FDA 510(k) clearance on 1985-08-22. The listed applicant is American Edwards Laboratories. The 510(k) number is K852759.

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

AMERICAN EDWARDS LABORATORIES FLEXISCOPE received FDA 510(k) clearance on 1985-08-22, under 510(k) number K852759.

Who is the listed applicant for AMERICAN EDWARDS LABORATORIES 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 LABORATORIES FLEXISCOPE?

The FDA product code for AMERICAN EDWARDS LABORATORIES 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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