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Waters Instruments, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K053169RM3 RENAL PRESERVATION SYSTEMJanuary 17, 2006
K042224RM3 RENAL PRESERVATION SYSTEMOctober 22, 2004
K971571RM3 RENAL PRESERVATION SYSTEM--CONTROL UNITJuly 29, 1997
K921519OXICOM-2100October 23, 1992
K911207OXICOMPLUSAugust 26, 1991
K863210VELCOM-100November 26, 1986
K862161OSC-80 OXIMETERAugust 18, 1986
K852909MVP - 6000November 14, 1985
K834408TX-2 THERMAL DILUTION CARDIAC OUTPUTAugust 23, 1984
K841876POLYURETHANE THERMAL DILUTION CATHETJuly 13, 1984
K813585WATERS ILEOSTOMY VALVEApril 9, 1982
K813494WATERS ILEAL RESERVOIR CATHETERDecember 31, 1981