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510(k) K854734

MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE by Medasonics, Inc. — Product Code DRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1986
Date Received
November 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Cardiac, External
Device Class
Class II
Regulation Number
870.5200
Review Panel
CV
Submission Type

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  • K961116 — FIRST BEAT/CARDIO BEAT/CALC (August 8, 1996)
  • K914862 — CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS (December 3, 1992)
  • K911453 — OBTRASOUND STETHOSCOPE FETAL CALC (June 20, 1991)
  • K882018 — MEDACORD PVL, PERSONAL VASCULAR LABORATORY (September 21, 1988)
  • K872292 — TRANSPECT TRANSCRANIAL DOPPLER (August 14, 1987)
  • K833588 — VASCULAR LABORATORY TREADMILL VT1 (November 14, 1983)
  • K837481 — BF24 DOPPLER MODEL P872 AND P874 (June 24, 1983)
  • K831393 — VASCULAB BLOOD PRESSURE CUFF (June 16, 1983)

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  • K161768 — LUCAS 3 Chest Compression System (November 9, 2016)
  • K153628 — ROSC-U Mini Chest Compressor (RMCC) (January 30, 2016)
  • K141809 — RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM (October 27, 2014)
  • K112998 — AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 (March 15, 2012)
  • K102068 — MINIATURIZE CHEST COMPRESSOR (MCC) (November 16, 2010)
  • K090422 — LUCAS 2 (June 17, 2009)
  • K072527 — AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (March 19, 2008)