ARGOS

Neurological Stereotaxic Instrument

3D LINE MEDICAL SYSTEMS S.R.L.

The following data is part of a premarket notification filed by 3d Line Medical Systems S.r.l. with the FDA for Argos.

Pre-market Notification Details

• Device ID: K061479
• 510k Number: K061479
• Device Name: ARGOS
• Classification: Neurological Stereotaxic Instrument
• Applicant: 3D LINE MEDICAL SYSTEMS S.R.L. VIA BERNARDO RUCELLAI 23 Milan, IT 20161
• Contact: Marco Luzzara
• Correspondent: Stefan Preiss; TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891
• Product Code: HAW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2006-05-30
• Decision Date: 2007-04-05
• Summary: summary