MAX IT— 510(k) K983438

Substantially Equivalent

Dorea, Inc.

FDA 510(k) clearance K983438 for MAX IT, Substantially Equivalent on 1999-02-08. Applicant: Dorea, Inc.. Device class: 2.

Clearance details

Applicant: Dorea, Inc.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1998-09-29
Decision date: 1999-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cairo, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.