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510(k) K855102

MONARK 869 ERGOMETER by Equilibrated Bio Systems, Inc. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1986
Date Received
December 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Balloon, Intra-Aortic And Control
Device Class
Class II
Regulation Number
870.3535
Review Panel
CV
Submission Type

Other clearances by Equilibrated Bio Systems, Inc.

  • K892705 — EBS2605 INFANT HUGGER (October 27, 1989)
  • K843996 — TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER (November 20, 1984)
  • K791294 — SPIROCAL (August 16, 1979)
  • K790410 — ADULT ZEE-FRAME (March 22, 1979)
  • K781509 — ZEE-FRAME (September 26, 1978)
  • K781386 — EBS 775 TONOMETER (September 14, 1978)

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  • K181122 — CARDIOSAVE Intra-Aortic Balloon Pump (May 31, 2018)
  • K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (October 12, 2017)
  • K162820 — AC3 Series IABP System (March 31, 2017)