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510(k) K903392

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

K903392 is an FDA 510(k) premarket notification submitted by Electromedics, Inc. for the device "ELECTROMEDICS BT422-120 AND BT422-40". The FDA issued a decision of Substantially Equivalent on September 6, 1990. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Electromedics, Inc. has at least 10 other 510(k) clearances on record.

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)

Other clearances for product code CAC

  • K241236 — XTRA Collection sets; XTRA Sequestration set X (August 16, 2024)
  • K240426 — Aventus Clot Management System (May 14, 2024)
  • K240584 — XTRA Autotransfusion System (with XTRA Bowl sets) (April 29, 2024)
  • K231782 — FlowSaver Blood Return System (80-101) (July 14, 2023)
  • K221483 — FlowSaver Blood Return System (February 17, 2023)
  • K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (November 15, 2022)
  • K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suc (September 3, 2021)
  • K210862 — Hemafuse System (July 29, 2021)
  • K210176 — FlowSaver Blood Filter (July 22, 2021)
  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)

FDA data resources