APOLLO

Table, Radiologic

VILLA SISTEMI MEDICALI S.P.A.

The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Apollo.

Pre-market Notification Details

• Device ID: K050190
• 510k Number: K050190
• Device Name: APOLLO
• Classification: Table, Radiologic
• Applicant: VILLA SISTEMI MEDICALI S.P.A. 11550 WEST KING ST. Franklin Park, IL 60131
• Contact: Veronica Meredith
• Correspondent: Veronica Meredith; VILLA SISTEMI MEDICALI S.P.A. 11550 WEST KING ST. Franklin Park, IL 60131
• Product Code: KXJ
• Subsequent Product Code: IXL
• Subsequent Product Code: KPW
• CFR Regulation Number: 892.1980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-01-27
• Decision Date: 2005-03-25
• Summary: summary