FLA · Class II · 21 CFR 876.5820

FDA Product Code FLA: Monitor, Temperature, Dialysis

Leading manufacturers include Nxstage Medical, Inc. and Organon Teknika Corp..

3
Total
3
Cleared
64d
Avg days
1981
Since

FDA 510(k) Cleared Monitor, Temperature, Dialysis Devices (Product Code FLA)

3 devices
1–3 of 3
Cleared Jun 16, 2014
NXSTAGE EXPRESS FLUID WARMER
K140623
Nxstage Medical, Inc.
Gastroenterology & Urology · 97d
Cleared Aug 27, 1984
FLUID WARMER
K842302
Organon Teknika Corp.
Gastroenterology & Urology · 77d

About Product Code FLA - Regulatory Context