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FDA 510(k)

AM-PEN SCREEN

K-Number: K782086 · 1979-02-01

ApplicantPfizer, Inc.
Decision Date1979-02-01
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AM-PEN SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 1979-02-01 under 510(k) number K782086. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AM-PEN SCREEN?

AM-PEN SCREEN is a medical device that received FDA 510(k) clearance on 1979-02-01. The listed applicant is Pfizer, Inc.. The 510(k) number is K782086.

When did AM-PEN SCREEN receive FDA 510(k) clearance?

AM-PEN SCREEN received FDA 510(k) clearance on 1979-02-01, under 510(k) number K782086.

Who is the listed applicant for AM-PEN SCREEN?

The FDA 510(k) record lists Pfizer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AM-PEN SCREEN?

The FDA product code for AM-PEN SCREEN is JTO.

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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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