OPTIMAX/ COMPACT 2— 510(k) K992818

Substantially Equivalent

Protec GmbH & Co. KG

FDA 510(k) clearance K992818 for OPTIMAX/ COMPACT 2, Substantially Equivalent on 1999-09-01. Applicant: Protec GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Protec GmbH & Co. KG
Product code: Code IXW
Device class: Class 2
Regulation: 21 CFR 892.1900
Advisory panel: Radiology
Date received: 1999-08-20
Decision date: 1999-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oberstenfeld, DE

Download summary PDF View on FDA.gov ↗

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