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510(k) K013349

ASTRONOMER PLUS SYSTEM by Ep Technologies, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2002
Date Received
October 9, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Ep Technologies, Inc.

  • K043257 — REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM (February 3, 2005)
  • 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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