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510(k) K042224

RM3 RENAL PRESERVATION SYSTEM by Waters Instruments, Inc. — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2004
Date Received
August 17, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Perfusion, Kidney
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

Other clearances by Waters Instruments, Inc.

  • K053169 — RM3 RENAL PRESERVATION SYSTEM (January 17, 2006)
  • K971571 — RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT (July 29, 1997)
  • K921519 — OXICOM-2100 (October 23, 1992)
  • K911207 — OXICOMPLUS (August 26, 1991)
  • K863210 — VELCOM-100 (November 26, 1986)
  • K862161 — OSC-80 OXIMETER (August 18, 1986)
  • K852909 — MVP - 6000 (November 14, 1985)
  • K834408 — TX-2 THERMAL DILUTION CARDIAC OUTPUT (August 23, 1984)
  • K841876 — POLYURETHANE THERMAL DILUTION CATHET (July 13, 1984)
  • K813585 — WATERS ILEOSTOMY VALVE (April 9, 1982)

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