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510(k) K862161

OSC-80 OXIMETER by Waters Instruments, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1986
Date Received
June 6, 1986
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)
  • K911207 — OXICOMPLUS (August 26, 1991)
  • K863210 — VELCOM-100 (November 26, 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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