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510(k) K011088

SIII ALARM AMPLIFIER by Stockert Instrumente GmbH — Product Code DTQ

K011088 is an FDA 510(k) premarket notification submitted by Stockert Instrumente GmbH for the device "SIII ALARM AMPLIFIER". The FDA issued a decision of Substantially Equivalent on May 2, 2001. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Stockert Instrumente GmbH has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2001
Date Received
April 10, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4220
Review Panel
CV
Submission Type

Other clearances by Stockert Instrumente GmbH

  • K042374 — STOCKERT SCP RHYTHM (September 23, 2004)
  • K041558 — STOCKERTIR PURGE CONTROL (APC) SYSTEM (July 2, 2004)
  • K032213 — STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP (August 29, 2003)
  • K023622 — STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 (November 21, 2002)
  • K022280 — STOCKERT CORONARY PERFUSION CANNULAE (October 11, 2002)
  • K022321 — STOCKERT V172-28 VENOUS FEMORAL CANNULA (October 9, 2002)
  • K020571 — STOCKERT CENTRIFUGAL PUMP CONSOLE (September 23, 2002)
  • K011838 — CENTRIFUGAL PUMP (February 5, 2002)

Other clearances for product code DTQ

  • K232291 — Essenz HLM, Essenz ILBM (August 24, 2023)
  • K221895 — Terumo Advanced Perfusion System 1 (April 18, 2023)
  • K221373 — Essenz HLM (March 9, 2023)
  • K210130 — Stockert S5 System (April 5, 2021)
  • K202125 — Century Perfusion System (March 7, 2021)
  • K190282 — Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (May 24, 2019)
  • K173834 — Quantum Pump Console (May 25, 2018)
  • K172220 — Advanced Perfusion System 1 (August 17, 2017)
  • K163531 — Advanced Perfusion System 1 (June 7, 2017)
  • K153376 — Advanced Perfusion System 1 (December 16, 2015)

FDA data resources