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510(k) K911207

OXICOMPLUS by Waters Instruments, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1991
Date Received
March 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Waters Instruments, Inc.

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  • K921519 — OXICOM-2100 (October 23, 1992)
  • 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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