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FDA 510(k)

EARLY DETECTOR

K-Number: K833369 · 1984-08-02

ApplicantWarner-Lambert Co.
Decision Date1984-08-02
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EARLY DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Warner-Lambert Co.. It received FDA 510(k) clearance on 1984-08-02 under 510(k) number K833369. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EARLY DETECTOR?

EARLY DETECTOR is a medical device that received FDA 510(k) clearance on 1984-08-02. The listed applicant is Warner-Lambert Co.. The 510(k) number is K833369.

When did EARLY DETECTOR receive FDA 510(k) clearance?

EARLY DETECTOR received FDA 510(k) clearance on 1984-08-02, under 510(k) number K833369.

Who is the listed applicant for EARLY DETECTOR?

The FDA 510(k) record lists Warner-Lambert Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EARLY DETECTOR?

The FDA product code for EARLY DETECTOR is KHE.

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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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