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510(k) K910935

MODIFIED PYROGEN TESTING by Electromedics, Inc. — Product Code DTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1991
Date Received
February 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class
Class II
Regulation Number
870.4260
Review Panel
CV
Submission Type

Other clearances by Electromedics, Inc.

  • K934964 — ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR (March 7, 1994)
  • K933832 — ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR (January 28, 1994)
  • K934355 — ELECTROMEDICS BLOOD HEAT EXCHANGER (December 3, 1993)
  • K930154 — EL2-SERIES BLOOD COLLECTION REERVOIR (July 1, 1993)
  • K926250 — ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR (February 19, 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)
  • 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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