Waters Assoc., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K811975MODEL 480 VARIABLE WAVELENGTH ULTRA VIOLJuly 27, 1981
K8024817FRENCH FLOW DIRECTED TRIPLE LUMEN CATHOctober 31, 1980
K801852MRM-2 OXYGEN CONSUMPTION MONITORAugust 20, 1980
K801431PAN-AM MYELOGRAM TRAYAugust 12, 1980
K791661SYSTEM CONTROLLER 720 SERIESSeptember 24, 1979
K7910264F STERILE BALLOON-LESS, CATHETER 913-28June 22, 1979
K782175CARTRIDGE HOLDER, RCM 100February 15, 1979
K790145SOLVENT DELIVERY SYSTEMFebruary 15, 1979
K781805CARDIAC COMPUTERS, CO-10 & CO-10RJanuary 29, 1979
K781915DATA MODULEJanuary 10, 1979
K781692CALIBRATOR, DYNAMICNovember 29, 1978
K781264PAB CONVENIENCE TRAYSeptember 20, 1978
K780245RECORDER, RE-100P HOT STYLUS STRIP CHARTMarch 27, 1978
K780031FLUORESCENCE DETECTOR MODEL 420January 20, 1978
K772311WISP MODEL 710January 12, 1978
K761166TC-1 CARDIAC OUTPUT COMPUTERDecember 9, 1976