510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Blood Establishment Computer Software And Accessories

Terumo BCT, Inc

The following data is part of a premarket notification filed by Terumo Bct, Inc with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

• Device ID: BK190333
• 510k Number: BK190333
• Device Name: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
• Classification: Blood Establishment Computer Software And Accessories
• Applicant: Terumo BCT, Inc 10811 W. Collins Ave. Lakewood, CO 80215 US
• Product Code: MMH
• CFR Regulation Number: 864.9165 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-22
• Decision Date: 2019-12-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05020583114012	BK190333	0