Blood Mixing And Weighing Devices

Device, Blood Mixing And Blood Weighing

Fresenius Medical Care North America

The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Blood Mixing And Weighing Devices.

Pre-market Notification Details

• Device ID: BK040005
• 510k Number: BK040005
• Device Name: Blood Mixing And Weighing Devices
• Classification: Device, Blood Mixing And Blood Weighing
• Applicant: Fresenius Medical Care North America 95 Hayden Avenue Lexington, MA 02420 US
• Product Code: KSQ
• CFR Regulation Number: 864.9195 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-01-29
• Decision Date: 2004-03-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04086000860765	BK040005	0
04086000860758	BK040005	0
04086000860741	BK040005	0