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FDA 510(k)

ESCREEN SYSTEM

K-Number: K003352 · 2001-03-20

ApplicantEscreen, Inc.
Decision Date2001-03-20
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ESCREEN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Escreen, Inc.. It received FDA 510(k) clearance on 2001-03-20 under 510(k) number K003352. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESCREEN SYSTEM?

ESCREEN SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-20. The listed applicant is Escreen, Inc.. The 510(k) number is K003352.

When did ESCREEN SYSTEM receive FDA 510(k) clearance?

ESCREEN SYSTEM received FDA 510(k) clearance on 2001-03-20, under 510(k) number K003352.

Who is the listed applicant for ESCREEN SYSTEM?

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

What is the FDA product code for ESCREEN SYSTEM?

The FDA product code for ESCREEN SYSTEM is LAF.

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Official Source

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