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510(k) K900104

TCPM II TOURNIQUET CUFF PRESSURE MONITOR by Electromedics, Inc. — Product Code KCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1990
Date Received
January 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Pneumatic
Device Class
Class I
Regulation Number
878.5910
Review Panel
SU
Submission Type

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  • K915737 — AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR (September 3, 1992)
  • K910238 — PORTABLE AUTO TRANSFUSION SYSTEM 500 (June 19, 1991)
  • K910935 — MODIFIED PYROGEN TESTING (May 16, 1991)
  • K902723 — ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 (December 13, 1990)

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