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

Blood Bank Computer Systems, Inc.

The following data is part of a premarket notification filed by Blood Bank Computer Systems, 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: BK090081
• 510k Number: BK090081
• 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: Blood Bank Computer Systems, Inc. 1002 15th St. Sw, Suite 120 Auburn, WA 98001
• Product Code: MMH
• CFR Regulation Number: 864.9165 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-12-23
• Decision Date: 2010-01-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860009119468	BK090081	0