WAVES

System, Perfusion, Kidney

WATERS MEDICAL SYSTEMS, LLC

The following data is part of a premarket notification filed by Waters Medical Systems, Llc with the FDA for Waves.

Pre-market Notification Details

• Device ID: K111521
• 510k Number: K111521
• Device Name: WAVES
• Classification: System, Perfusion, Kidney
• Applicant: WATERS MEDICAL SYSTEMS, LLC 2112 15TH ST. N.W., SUITE A Rochester, MN 55901 -0716
• Contact: Robert Warren
• Correspondent: Robert Warren; WATERS MEDICAL SYSTEMS, LLC 2112 15TH ST. N.W., SUITE A Rochester, MN 55901 -0716
• Product Code: KDN
• CFR Regulation Number: 876.5880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-01
• Decision Date: 2012-02-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
BI54W39301400070	K111521	000
B154W39300050150	K111521	000
3930005014	K111521	000
B154W39300050110	K111521	000
3910140001	K111521	000
B154W39201400226	K111521	000
B154W39000420000	K111521	000