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510(k) K926250

ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR by Electromedics, Inc. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1993
Date Received
December 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

Other clearances by Electromedics, Inc.

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  • K934355 — ELECTROMEDICS BLOOD HEAT EXCHANGER (December 3, 1993)
  • K930154 — EL2-SERIES BLOOD COLLECTION REERVOIR (July 1, 1993)
  • K925412 — ELECTROMEDICS TISSUE TRAP/ #TT280 (February 5, 1993)
  • 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)
  • K903392 — ELECTROMEDICS BT422-120 AND BT422-40 (September 6, 1990)

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