INBODY

Analyzer, Body Composition

BIOSPACE CORPORATION LIMITED

The following data is part of a premarket notification filed by Biospace Corporation Limited with the FDA for Inbody.

Pre-market Notification Details

• Device ID: K130777
• 510k Number: K130777
• Device Name: INBODY
• Classification: Analyzer, Body Composition
• Applicant: BIOSPACE CORPORATION LIMITED 8870 RAVELLO CT Naples, FL 34114
• Contact: Daniel Kamm, P.e.
• Correspondent: Daniel Kamm, P.e.; BIOSPACE CORPORATION LIMITED 8870 RAVELLO CT Naples, FL 34114
• Product Code: MNW
• CFR Regulation Number: 870.2770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-21
• Decision Date: 2013-11-25
• Summary: summary