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510(k) K043257

REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM by Ep Technologies, Inc. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2005
Date Received
November 24, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by Ep Technologies, Inc.

  • K013349 — ASTRONOMER PLUS SYSTEM (April 9, 2002)
  • K003452 — POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D (December 7, 2000)
  • K940167 — DIAGNOSTIC I CATHETER (August 2, 1994)
  • K940168 — DIAGNOSTIC II CATHETER (July 27, 1994)
  • K924108 — TRACFINDER II (December 16, 1993)
  • K924109 — STEEROCATH II (December 16, 1993)
  • K913375 — TORQUE TUBE STEEROCATH(TM) (October 25, 1991)
  • K903880 — FRANZ(TM) STEERABLE COMBINATION CATHETER (October 12, 1990)
  • K900765 — STEEROCATH(TM) (May 7, 1990)
  • K900452 — QUATTRO CATHETER (March 14, 1990)

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