BIOSPACE

System, Measurement, Blood-pressure, Non-invasive

BIOSPACE CORPORATION LIMITED

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

Pre-market Notification Details

• Device ID: K131064
• 510k Number: K131064
• Device Name: BIOSPACE
• Classification: System, Measurement, Blood-pressure, Non-invasive
• Applicant: BIOSPACE CORPORATION LIMITED 8870 RAVELLO CT Naples, FL 34114
• Contact: Daniel Kamm
• Correspondent: Daniel Kamm; BIOSPACE CORPORATION LIMITED 8870 RAVELLO CT Naples, FL 34114
• Product Code: DXN
• CFR Regulation Number: 870.1130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-04-16
• Decision Date: 2013-09-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08809209590686	K131064	000
08809209590747	K131064	000