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FDA 510(k)

AMER. EDWARDS LAB FLEXISCOPE

K-Number: K842410 · 1984-11-05

ApplicantAmerican Edwards Laboratories
Decision Date1984-11-05
Product CodeHRK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AMER. EDWARDS LAB 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 1984-11-05 under 510(k) number K842410. The device is classified under product code HRK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMER. EDWARDS LAB FLEXISCOPE?

AMER. EDWARDS LAB FLEXISCOPE is a medical device that received FDA 510(k) clearance on 1984-11-05. The listed applicant is American Edwards Laboratories. The 510(k) number is K842410.

When did AMER. EDWARDS LAB FLEXISCOPE receive FDA 510(k) clearance?

AMER. EDWARDS LAB FLEXISCOPE received FDA 510(k) clearance on 1984-11-05, under 510(k) number K842410.

Who is the listed applicant for AMER. EDWARDS LAB 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 AMER. EDWARDS LAB FLEXISCOPE?

The FDA product code for AMER. EDWARDS LAB FLEXISCOPE is HRK.

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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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