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510(k) K903392

ELECTROMEDICS BT422-120 AND BT422-40 by Electromedics, Inc. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1990
Date Received
July 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Autotransfusion
Device Class
Class II
Regulation Number
868.5830
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)
  • K910935 — MODIFIED PYROGEN TESTING (May 16, 1991)
  • K902723 — ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 (December 13, 1990)

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